REGULATIONS – Regulatory Overlord The Regulatory Overlord Chronicles Mon, 31 Oct 2016 14:14:52 +0000 en-US hourly 1 Saving lives is worth celebrating, CDC Reports Sharp Decline in Foodborne Illnesses Tue, 12 Feb 2013 05:49:03 +0000 more »]]> Saving lives is worth celebrating....

Saving lives is worth celebrating….

Foodborne illnesses are defined as the illnesses caused by pathogens that enter the human body where food is the carrier. They may be transmitted via close contact with an infected person or ingestion of contaminated foods. The epidemic nature of food borne diseases is a known cause of concern amongst the respective regulatory and compliance authorities. However according to the CDC’s (‘Centers of Disease Control’ in the United States) most recent report released on 25th January, 2013, a sharp decline in the number of deaths and reported cases of foodborne illnesses have been observed.

In the fields of science and technology, facts and figures are known to speak for themselves. Thus, a 1% decline in the number of reported cases may not seem much, but it accounts for roughly 200 individuals prevented from infection, and 12 from hospitalization. Additionally, there is a 32% decline compared with the mean off the last five years that the CDC report reflects. Since foodborne diseases spread rapidly through close contact and ingestion of contaminated food, or from infected persons, the decrease observed is definitely worth a celebration for industry and regulators alike.

At first glance, the CDC report would not enable an individual to realize the stark decrease or significance of 32% in cases reported. However, a closer examination and evaluation of the report will shed light on the subject. The bi yearly nature of the current report does not help one realize the facts and figures as they may appear to be elevated, but that is certainly not the case.

The facts and figures presented in the report are as follows:

Latest Report:Illnesses: 29,444Hospitalizations: 1,184Deaths: 23 Previous report:Illnesses: 23,152Hospitalizations: 1,276Deaths: 22

The above figures might indicate an elevation but CDC used the new procedure named ‘new reporting form and online data’. This new method may not display results in black and white but this does not mean they are incorrect. A detailed study of the report helps shed light on the underlining cases and its contents.

It must be kept in mind that change of technology cannot change the figures of results, as so is also admitted by CDC. The organization, nonetheless, is unsure about the reasons of the turndown in the outbreak reports.

Some trends are worth nothing in the current report:

  • Among the 790 outbreaks with a laboratory-confirmed illness, norovirus was the most commonly reported infection, accounting for 42% of outbreaks; followed by Salmonella, with 30% of outbreaks.
  • Of the 29,444 outbreak-related illnesses, 1,184 (4%) resulted in hospitalization.Salmonella caused the most outbreak-related hospitalizations (49%), followed by Shiga toxin-producing E. coli (16%), and norovirus (9%).
  • Outbreaks caused by some pathogens were particularly severe. For example, Listeriaoutbreaks resulted in the highest proportion of persons hospitalized (82%), followed byClostridium botulinum (67%), and paralytic shellfish poisoning (67%).
  • Among the 23 deaths, 22 were linked to bacteria (9 Listeria, 5 SalmonellaE. coli O157, 3Clostridium perfringens, and 1 Shigella), and 1 was linked to norovirus.

The report also hypothesizes the decline observed in food borne diseases is mostly in regards to non-virus outbreaks. These are normally transmitted through a variety of routes, mainly via close contact with the pathogen or infected persons. Furthermore, through the introduction of ‘National Outbreak Reporting System’, the electronic reporting of cases of foodborne illnesses has been enabled and allows for greater . Although no conventional reasoning has been put forth, this new technique is rather a commendable success. Thus, saving lives is as good a reason as any for celebration.

The Chasmic Shift in Disruptive Business Climates Wed, 09 Dec 2009 21:16:55 +0000 The Chasmic Shift in Disruptive Business Climates

The Chasmic Shift in Disruptive Business Climates

It has been a few months since I have had an opportunity to write for pleasure. After completing my doctoral work on August 25th, working on a major global submission, and teaching 2 sections of Healthcare Marketing and Communications at West Virginia University, I needed some time off to focus on other initiatives. But, there is nothing like a break from the absence of grading 20 papers and discussion boards weekly to rekindle interest and chime in on the debates.

On Tuesday, September 15th, I was session leader (Combination Products in Asia – Regulatory Challenges and Successful Development and Approval Strategies) at the Regulatory Affairs Professional Society Annual Conference and it was noticeably smaller as compared with the Boston conferences of 2007 and 2008.  Yes companies reduced the numbers of attendee, but there were less companies overall. This year has seen victims of shrinking capital markets, disappointing FDA feedback and company decisions to forgo developmental targets and potential indications owing to funding priorities.

Traditionally, FDA approval of new drugs used to be based upon sponsors’ demonstration of safety and effectiveness via a Biologics License Application (BLA), New Drug Application (NDA), Premarket Notification (510k) or Premarket Application (PMA), and on the basis of information submitted in support of the marketing application. Based on bureaucratic learning, past FDA errors and resulting criticisms, FDA divisions have added clinical relevance and utility as benchmarks for approval and standard setting.

Gone are the days of business models where companies created entire business structures that revolved around one or two developmental compounds in clinical trials. The industry has moved from a history of exuberant excesses to lean manufacturing, better evidence for reimbursements and business practices for long term profitability.  Now we are in the era of “healthcare reform” where the current healthcare crisis has been characterized as a demonization of the insurance industry, similar to the “evil pharma” campaign that characterized the prescription drug debates.

Though the “reform friendly” medical products industry is distinguishable from other health care services because it provides tangible products, the industry remains vulnerable. Current indicators suggest that government and legislative policy has resulted in negative confidence of future growth. The Obama Administration’s ambitious foray into “health reform” amounts to a de facto restructuring of one-sixth of the ~$15 trillion US economy and ushers the question: How will this shape business models and more importantly, how will medical products and healthcare companies do business in a post-reform environment?

Following are a few obvious guidelines for evaluating the “post reform” healthcare paradigm.

Universal Coverage = More Governmental Control

Common sense dictates that universal coverage will lead to a fully funded government mandate and obligation. This will ultimately result in cost containment and thus limit access and choice.

More Healthcare Demand without Increasingly Supply = Higher Than Projected “True Economic Costs”

Economic fundamentals dictates that increasing demand for healthcare consumption by extending coverage to the uninsured without concomitant policies aimed an incentivising facility construction  or adding more physicians, will increase healthcare costs on an individual and governmental level. The unanswered question is which of the stakeholders (employers, industry, government, patients or providers) will end up covering the bill.

Reform = Different or Disproportionate Impacts on Primary and Specialty Medical Products

Expanding access to healthcare for the uninsured will increase demand for primary care medical products used to treat and prevent chronic conditions. This will have a disproportionate impact on the higher priced specialty medical products used to treat and manage diseases targeted to smaller patient groups and which are marked by higher co-pays and limited or no reimbursements.

Disconnected Expert Panels = Potential for Danger

Attempts to shield the government from the appearance of political involvement by relying on expert panels to decide on coverage and reimbursements can be open to “stakeholder pressure.” These elites who are not necessarily vested and politically insulated in an ivory tower can be a recipe for danger. Outside US, the experience with these types of panel suggest that they encourage companies to utilize patient groups and other strategies to influence coverage and access.

Piecemeal Approaches = Similar Outcomes

The theory of structuration as proffered by Anthony Giddens (1986) emphasizes “a differentiation between the concepts of ‘structure’ and ‘system’” (Giddens, 1986, p. 17). Giddens points out that “structure is a set of rules, systems ….comprise… human agents” and structuration “is….. the duality of structure” (Ibid., p. 25). In examining congress, the underlying construct is in seeking a balance or duality between the risks of nothing doing anything versus the risks of doing to much. Regardless of whether full reform is achieved or negotiated piecemeal stop gap measures, pressures will continue to have an effect on the structure and we are likely to revisit again in 10-20 years.


A fundamental tenet of healthcare economics is premised on the idea that we are all born with a stock of good health and our lifestyle choices and access to healthcare determines appreciation or depreciation. The fundamental question has been muddled and is simply whether we as Americans support a “floor” not a “ceiling” to cover those less fortunate.


Giddens, A. (1986). The Constitution of Society: Outline of the Theory of Structuration. University of California Press.

Talkback: Response to Article in Nature, A To-Do List for the New FDA Commissioner, by Susan Okie, M.D. Thu, 04 Jun 2009 00:37:04 +0000 FDA Centennial-1906-2006

FDA Centennial-1906-2006


The article in Nature by Dr. Susan Okie titled, A To-Do List for the New FDA Commissioner, was an unfair indictment of an agency that still maintains the world’s “gold standard” and has done so for over 100 years. It was a naive perspective, filled with partial anecdotes, selected excerpts, and platitudes. Dr. Okie asserts that the agency has “serious systemic problems” and recants salacious sections from reports describing the agency as “burdened by ever-expanding responsibilities, underfunded and understaffed, lacking modern scientific expertise, and equipped with a dangerously outmoded information-technology infrastructure. The problems within the FDA is not that of a “cancer,” but rather the failure of a legislature who as history demonstrates, must have tragedy, followed by public outrage, before expanded legislation or legislative authority is granted to the FDA.

Dr. Okie disingenuously surmises that the perception of the agency is “slow to act, secretive, and subject to influence by political and corporate interests.” The burden for FDA employees is that their decisions can kill millions by a single approval making the responsibilities for protecting the public from unsafe regulated products onerous. It is no secret that bureaucrats respond to incentives and FDA is no exception. Any public or congressional backlash will cause the agency to be more risk averse. The agency makes decisions that affect the lives and health outcomes of millions of Americans daily. If Dr. Okie had to sign a letter authorizing the availability of a new medical product to over 300 million Americans, what kind of information (and how much of it) would she want?

In practice, regulations are implemented in a very stylized way with ambitious goals and preambles that spell out congressional intent without practical considerations. In the case of the FDA, Congress tasked the agency with mandates to achieve certain objectives which are impossible based on allocated resources. Though FDA has discretion within its purview to set regulations which are consistent with its mission, often times these are influenced by external stakeholders such as the public, industry, congress and overlapping federal, state and local governmental authorities, all with differing interpretations of the agency’s role in fulfilling regulatory oversight responsibilities.

Dr. Okie’s perspective restates the obvious – that we are faced with problems for which the current FDA structure is inadequate to address. What we have seen out of Congress in the last twenty years tends to be performance based, placing and holding the FDA to approval targets and laborious reporting requirements without concomitant resources. Many agree that Congress needs to grant the FDA legislation that allows greater independence and less political interference. This is a tall feat for an institution that starts campaigning after the last election and is influenced by over 1,100+ registered drug lobbyists (add devices, foods, cosmetics and other regulated products and it would equal 2200+). Congress needs to empower FDA with the flexibility in meeting current and future challenges such as supply chain globalization and the sourcing of active ingredients/components from disparate sources and countries with lackluster regulatory and safety practices. These are issues that could potentially derail the confidence in the safety of the American medical product supply.

Quoted former commissioner Donald Kennedy idealistically declared that “the commissioner has legal authority to take actions to protect the public health and has considerable power to make administrative changes without congressional action.” The power is vested in the Secretary of HHS (or designates), but the real power is in the process of regulatory oversight via rulemaking which is subject to approval by the Office of Management and Budget (OMB), an executive agency. This means that new proposals for federal regulations from regulatory agencies must be submitted for review. The OMB via its unit, the Office of Information and Regulatory Affairs (OIRA) applies cost benefit analysis to new regulations before approving them. They sometimes negotiate with the agency concerned over amendments and in some cases reject changes outright. Once approved, changes are formally published in the Federal Register for public comment.

Dr. Okie fails to recognize that that the introduction of a new product to market is risky. She quotes a highly critical excerpt from the 2006 Institute of Medicine report on drug safety, but failed to mention the pronouncement that, “it is impossible to have complete information about drug safety at the time of approval, because drugs’ mechanism of action are complex; pre-approval clinical testing is generally conducted in controlled settings in defined, carefully-selected populations; and insufficient sample sizes to detect serious but rare adverse effects.” The FDA can only make decisions based on information submitted, and to imply that the agency should have a crystal ball is audacious.

If we look at the Black Box warnings required by the FDA to address the class of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs) we can witness parallels. There were revelations of an increased risk of suicidal thoughts in teens. The Industry argued that past history of such FDA warnings revealed that they create barriers to care and unnecessarily frighten families away from seeking treatment. While this is true, had the FDA not required such label warnings and an incident occurred, the agency would once again be forced to shift the pendulum towards more stringent requirements. If the FDA did not act based on scientific evidence they received, no matter how minute, they would have been crucified in case “suicidal thoughts” manifested into suicidal acts. In essence, the FDA is damned if they do and damned if they don’t.

Safety is not absolute because it involves an overall assessment of benefit vs. risk. Absolute safety is impossible as it requires absence of injuries and death. Safety is not exclusive; it necessitates a comparison across medical products and interventions and is only known with a product’s “real world” experience. Safety is not static, as we have seen time and time again; a safe drug today may be “unsafe” and outmoded tomorrow. It comes down to experimental risk versus situational risk that is often subjective and open to various interpretations ex-post versus ex-ante.

In summary, Dr. Okie incorrectly implies that the FDA faces a crisis of confidence. The crisis of confidence is in a Congress who needs to show independence and empower the FDA legislatively and financially to increase its own scientific expertise and new skills to meet current and emerging challenges. Any failure would result in an agency outmatched by private industry with lost relevance and public trust. The agency’s reputation is damaged but it is not destroyed. They are tasked with restoring a once stellar reputation and faced with a public worried about its ability to protect it, an industry worried about declining NMEs and what they perceive as a more conservative FDA posture in light of recent events. Yes, recent withdrawals and recalls have caused appropriate concern and resurged questions regarding the FDA’s mission and whether a new framework or drastic changes are required to ensure that the FDA retains its position as the “gold standard.”The FDA’s modern history is marked by a stellar and successful dual mission of protecting the public from unsafe and ineffective regulated products. What is unacceptable is any insinuation that FDA action is based on influence or commerce and not purely science.


Institute of Medicine Report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. 2006

Center for Public Integrity study of disclosure records shows. Spending on Lobbying Thrives,

Drug and health products industries invest $182 million to influence legislation

The Future of Convergent Technologies Wed, 06 May 2009 01:05:57 +0000 more »]]> BIOMEDevice Forum 2009

BIOMEDevice Forum 2009

(Report from BIOMEDevice 2009 Executive Forum)

I took time off to finalize my doctoral thesis draft and research bleeding edge companies presenting at BIOMEDevice 2009 held at Boston Convention Center on Tuesday April 21st through Wednesday, April 22, 2009. BIOMEDevice Forum is coined by the organizers Canon Communications LLC “Cancom”, as “New England’s premier executive-level conference focusing on convergence and cross-sector collaborations among companies in the biotechnology, medical device, IVD, and pharmaceutical industries.” The theme was convergence and going beyond the simple combination and complementary, to integration of disciplines for developing products that echo the era of translational medicine. Combination implies that products are developed as standalone components to be used jointly. Convergence really aims to blur the line between two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic). What makes convergence so exciting is that when it is applied to life sciences, the result is a cornucopia of advances in diagnosis, prevention, treatment and management of disease and medical conditions.

I participated in the Executive Forum and like previous years, the lists of invitees included CEOs, CFOs, R&D executives from mature and emerging life sciences firms, investors, industry analysts, academia and entrepreneurs with novel approaches and technologies for solving old problems and new technologies with unique applications.

The two-day event brings together key players involved in investing, partnering, licensing, and developing business opportunities in the rapidly growing market for innovative healthcare products. It was sponsored by R&D Directions (focuses on pharmaceutical companies’ R&D business strategies and decisions), IVD Technology (focuses on diagnostics technologies—including research, development, and manufacturing), Massachusetts Biotechnology Council and Massachusetts Medical Device Industry Council (MassMEDIC), whose president Thomas J. Sommer, I had a very pensive and enlightening discussion during lunch on day one.

My most memorable presentation was that of Imran Nasrullah, JD., Chief Business Officer, Massachusetts Biotechnology Council and a former Millennium Pharma colleague. Imran cleverly compared the 150th anniversary of Darwin’s evolutionary theory On the Origin of Species to the evolution of life science business models. If we look at life science business models of the past, we see companies building an entire company infrastructure to support a few investigational candidates without having a product on the market. The challenge to innovation can be best described in terms of selective policy pressures. Whether it is healthcare reform, FDA inefficiencies or patent reform, these all create a downward pressure on innovation which attenuates the pipeline for life saving medical products.

I sat next to Prof. Michael J. Cima, a Sumitomo Electric Industries Professor of Engineering and Faculty Director, Lemelson-MIT Program at lunch on day one. Dr. Cima commented that the real value lies in drugs used in procedures i.e those that allow procedures to be used in new settings. These can be in the form of enabling technologies or site or delivery or systemic delivery advances. Dr. Cima’s research has spawned a number of companies and two were represented Tengion (developing new human organs and tissues that are derived from a patient’s own cells. Speaker: Gary Sender, CFO) and MicroCHIPS (pioneering intelligent implanted devices designed to improve the health of millions of people with chronic conditions that require careful monitoring and precise therapy. Speaker: Maggie Pax, Vice President, Business Development).

The convergence of biology, chemistry, photonics, materials science, engineering, robotics, epidemiology and mechanics for translational medicine points the way forward. However, creating convergent products raises a spectrum of unique business, technical, and regulatory questions.  Developers must recognize, early in the process, when the product design assumes characteristics of a combination product, convergent product or virtual combination (product is packaged separately and the package inserts or instructions for use specifically mention the use of another product by brand name, requiring mutually conforming labeling). It may even change the Primary Mode of Action determination for deciding which FDA center will act as lead in reviewing the marketing application. The FDA received 333 original applications for combination products in FY 2007. A 42 percent increase from the 235 original applications for combination products in FY 2006. The number of intercenter consulting reviews increased to 390 for FY 2007 from 335 in FY 2006 representing a 16 percent increase in intercenter consults. Recent examples of approved combination products can be found at:

Historical Perspectives

2003-2007 Combination Products FDA Marketing Applications

2003-2007 Combination Products FDA Marketing Applications

Combination products have been in existence for many years.  By their nature, they raise unique challenges and have produced more than its share of controversy within the medical community.  The official history of combination products did not start until after 1990.  The Safe Medical Devices Act (SDMA), Section 503(g) was established at that time. Though worthy of explicit recognition in the Safe Medical Devices Act of 1990, combination products were still perceived as a theoretical regulatory problem. Combination products were seen as products of the future, whose potential was yet to be realized. As device and pharmaceutical industries continue to merge or partner to offer new products, it is revolutionizing the healthcare industry. Many pharmaceutical companies started partnering with medical device and biologic firms to formulate more “combination products,” and by the end of 2002 it was safe to say that the future was here. As we go beyond 2009, these products are a growing market with great potential.

Some estimates forecast that the combination products market could increase from approximately $6 billion in 2004 to nearly $10 billion by 2009 (“Regulations, Guidances in the Works for Rapidly Advancing Combination Products Sector”; Food and Drug Letter, Issue No. 717, February 11, 2005). Others estimate that combination drug delivery products alone are growing at an annual rate of 14 percent, an increase expected to add up to $38 billion in yearly sales by 2008 (“Drug-Device Makers Can Expect New Guidance”; AAMI News, February 2005). Furthermore, BCC Research Inc. estimates that the total global value of the drug-device combination products market will increase from $5.4 billion in 2004 to $11.5 billion in 2010 (“Drug-Device Combinations”, BCC Research, June 2005). Cardiovascular applications currently dominate, with 88% market share but expect to see those numbers decline as convergent products and platforms mature.

There are three (3) paramount issues that need to be addressed when a company is considering the development of convergent products.
1. Organizational Considerations (which I will not address)
2. Business Considerations
3. Regulatory Considerations

Regulatory Considerations

Regulatory Approaches to Combination Products

Regulatory Approaches to Combination Products

Regulatory Issues are always important since it is the only pathway by which a product can be marketed after it meets statutory requirements for approval and the adequate writing of directions for use (DFU) or package inserts (labels). Up until the time they are combined, drugs and biologics comply with cGMP (current Good Manufacturing Practices), devices comply with QSRs (Quality Systems Regulations) regulation but once the constituents come together and form the combination product:  BOTH SETS OF REGULATIONS ARE APPLICABLE.

The conventional wisdom at the FDA was that the primary mode of action was a determinant factor for the designating primary jurisdiction amongst the centers (CDER, CBER & CDRH). The FDA then promulgated 21 CFR Part 3 – Product Jurisdiction.  This regulation specified how the FDA was to determine which center was designated to have the primary jurisdiction for the premarket review and regulation of the combination product. By using these laws, regulations, and the Intercenter Agreements, a sponsor begins to determine the regulatory path for its product.

The challenges faced most often by sponsors are:

  • Absence of a pre-defined regulatory pathway to rely on for conformity
  • No specific submission process or marketing application
  • FDA regulations/practices differ for drugs, biologics and devices
  • Different cultures between CDER, CBER and CDRH
  • Companies are forced to work within the current statutory framework

Business Considerations

Business considerations for the development of convergent products are important. This is especially true when two parties are involved and the Intellectual property is not jointly owned or licensed.

The primary considerations to be analyzed are:

  • Who will fund the project?
  • Who owns the intellectual property?
  • Where will the product be developed, which facility?
  • What company’s sales force will sell the product?
  • Is there a mechanism in place for second-generation products to be produced?

Business actions can reduce the regulatory burden and it is incumbent on sponsors to look at ways to reduce regulatory burden.

These can be in the form of:

  • Adjusting the labeling claims, generalizing them as not to be tied to a single drug, biologic, or device.
  • Investigate whether or not there are other drugs, biologics or devices that are consistent with the labeled indication of the convergent product.
  • Adjust the packaging as to separate the drug, biologic and device components.
  • For post-marketing considerations, segmenting drug and device manufacturing may help to minimize some of the registration and GMP conflicts.

The Future – the big problem with the next big thing

Convergent products appear to be the wave of the future and technology will continue to advance for different combinations and continued development of nanotechnology and drug delivery systems. Pharmaceutical companies are also developing combination products and that will present its own set of challenges and inefficiencies.

Waves of promising new technologies come and go and entrepreneurs and media never seem to grow tired of oversimplification and buzzwords. In the past, venture capitalists swarmed and poured money into antisense, gene delivery, wound healing, rational design, genomics, proteomics, RNAi and now nanotechnology. If there is one thing we should have learned by now about medicine, it is that human biology does not quickly, predictably or inexpensively yield its secrets.

Real advances in medicine will continue to come from groups intensely focusing on a specific disease or drug delivery process, and bringing to bear every piece of ingenuity they can find—be it nano, micro or whatever. I can live with the idea and the words ‘convergent technologies’ so long as the objectives of the products that come from it are not oversimplified or concatenated in more buzzwords.

It is important for companies to:

  • Explore what precedents exist for the likely combination, i.e., find drug-device, biologic-device, drug-biologic and device-drug-biologic product examples.
  • Use the request for designation (RFD) and primary mode of action (PMOA) concepts to your advantage in bringing products to market more efficiently.
  • Understand how the cultural and philosophical differences between CDER, CBER and CDRH impact the FDA approval process.
  • Avoid pharmaceutical-nutraceutical and medical device-nutraceutical combinations.
  • Understand the manufacturing challenges of combination products, i.e., sterility, shelf-life, packaging, etc.
  • Learn from drug-eluting stents.
  • Understand the challenges of convergence.
  • Learn how companies communicate with drug, biotech and medical device – i.e. you don’t speak the same language.
The medical device industry and the role of CDRH Fri, 10 Apr 2009 02:49:19 +0000 more »]]>

A current pacemaker. Future devices are getting smaller and more complex.

A current pacemaker. Future devices are getting smaller and more complex.

The public trust manufacturers of medical products to develop and commercialize devices that are safe for humans. There are many types of medical devices varying in complexity, some as simple as contact lenses and others, life saving devices such as a pacemaker. In many cases these medical products perform as expected and last for the duration of the recipient’s lifetime or expected life of the device. Other times they fail and possible reasons for failure include, improper manufacturing, malfunction, breakage or erosion, all possibly resulting in serious injury to the device recipient. Implanted devices are being used for longer periods of time and in younger populations, presenting unique challenges as current devices may not have been designed for such a life span. This makes it difficult for Center for Devices and Radiological Health (CDRH) to communicate risk/benefit to multiple audiences in a way that is timely and balanced.

FDA’s CDRH has a mandate to ensure that new medical devices are safe and effective before they are marketed and monitor devices throughout the product life cycle, including a nationwide postmarket surveillance system. CDRH also has to assure that radiation-emitting products, such as microwave ovens, TV sets, cell phones, and laser products meet radiation safety standards. This mandate is an awesome responsibility presenting many challenges to CDRH who approves or clears a product after reasonable assurance of the safety and effectiveness has been scientifically demonstrated.

Advances in medical device technology have presented many challenges to CDRH. Adverse events are widely under-reported by users and numerous reports are made with inadequate information about how the device was used (condition/circumstance) and what may have caused the problem. This means that there is an inherent difficulty in identifying the specific device involved. Part of the problem is further compounded by the miniaturization of medical devices which are designed smaller and vary in complexity. This means that there are fewer margins for error. From surgical sutures and contact lenses to prosthetic heart valves and diagnostic imaging systems, these require that attention of qualified reviewers for an ever increasing pre-marketing submission environment.

The medical device market can be characterized as an industry where innovation, advancement, rapid growth and the complexity of devices are increasing. Many of these devices presented to CDRH are the first of their kind, such as a robotic arm that can operate a variety of surgical tools with tremendous precision. Other high-tech devices are designed to prevent, diagnose or treat cancer, heart disease, impaired vision and hearing, and other health problems. Current devices lack unique and universal identifiers and healthcare providers generally do not document device use in patient records. Manufacturers are continually producing modified versions of their products which mean that multiple versions may exist.

In the current economic climate, many firms are facing increasing competition and realizing that new FDA guidances and regulations are increasing operating costs. This has resulted in device firms being acquired by other companies in an attempt to gain economies of scale and solidify core competencies. There are cases of devices being used “off-label,” used by non-professionals and a shift to medical devices for home use, such as diagnostic tools. These changing realities present CDRH which more challenges in terms of post-market surveillance and with a limited field of resources; the agency is clearly unable to deliver on all fronts.

SUMMARY Government Accountability Office (GAO)
REPORT LINK: GAO-09-190 January 15, 2009

Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process

The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process. The FDA Amendments Act of 2007 mandated that GAO study the 510(k) process. GAO examined which premarket review process–510(k) or PMA–FDA used to review selected types of device submissions in fiscal years 2003 through 2007. GAO reviewed FDA data and regulations, and interviewed FDA officials.
In fiscal years 2003 through 2007, as part of its premarket review to determine whether devices should be permitted to be marketed in the United States, FDA:

(1) Reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90 percent) of these submissions;

(2) Reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67 percent) of these submissions; and

(3) Reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78 percent and 85 percent, respectively, of these submissions.

Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete. GAO found that in fiscal years 2003 through 2007 FDA cleared submissions for 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process. FDA officials said that the agency is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so.

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Introduction to the Nanotechnology series……. Tue, 07 Apr 2009 02:29:38 +0000 more »]]> The potential and benefits of nanotechnology are promising and unknowingly dangerous

The potential and benefits of nanotechnology are promising and unknowingly dangerous

The series on nanotechnology will address many important and foundational questions posed in the entry and commercialization of novel particles employing novel technology and useful in multiple applications and settings. The folowing are a few issues that come to mind.

  • Quick Primer:
    0 Prior to 2004, products using nanoparticles or nanotechnology methods were not subject to any regulation.
    0 Current regulations fall under Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) but no new regulatory authority has been granted to FDA.
  • Financial Challenges:
    0 This presents a challenge to firms and investors who driven by fear of lawsuits due to anticipated events, and the insurance industry that covers risk.
    Workers may be exposed to potential harmful nanoparticles ehich suggests that in the event of adverse health effects they will need to be covered in later years .
    0 The challenge is that the nanotechnology industry could quite possible get killed before its starts and must promote more research, self governance and ethical guidelines.
  • Regulatory Challenges:
    0 Regulators are faced with the challenge of protecting the public and fostering scientific and technological advancements.
    0 The paucity of toxicity data and the ethical issues of exposing human subjects to very high concentrations of nanoparticles will continue to be a challenge for risk assessors and regulatory alike.
  • Social Impact:
    0 Consumers are uninformed as to whether products they purchase contain nanoparticles or use nanotechnology methods and do not have the choice to buy or steer clear of such products.
  • Quick Conclusion:
    0 The current industry and regulatory knowledge of the technology and it’s implications are inadequate for risk assessment purposes.
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Plan B – Feminism as Practice & Theory Thu, 02 Apr 2009 03:49:59 +0000 more »]]> Plan B – Feminism as Practice & Theory

Plan B – Feminism as Practice & Theory

On Tuesday, March 24, 2009 U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor’s order. He also alleged in his 52 page ruling that “FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays.” LINK TO THE DECISION

The feminist principle is evident throughout history as demonstrated by the role women played in various civilizations. Women have always stood as a symbol to be possessed and controlled. Men have gone to wars over them and even today their bodies are censured in one way or another. From Janet Jackson’s “wardrobe malfunction” to breast feeding in public. Theirs was a struggle for equality but also a struggle to ensure that different voices were considered. They can be credited with instilling and ensuring a voice of conscience in American society. Their ability to procreate and bear men’s progeny makes them have a unique role in society. One can argue that it has created a system that is based on making them dependent on men for survival.

As society is a social construct, there tends to be a male dominated ideology and arguably a “white male” dominated ideology. It is on this playing field an adversary competes. The rules have been codified by “white males” for the benefit of ‘white males.” Mastering skills and competence is not only a necessity but a requirement to participate. History has shown that marginalized people have always come together to seek common interest and diverge when those interests collide. The feminist movement was not without varying incestuous alliances with other interest groups all of vying for advancing various agendas.

It would be hard to dissect what underlying assumptions are useful and limiting, without first looking at the various lessons learned. The feminists were successful as a movement and in redefining the role of women in American society. We hear the word “deconstruction” all the time. It was a postmodern feminist who theorized “that when you get down to it, there is no such thing as justice, beauty, or truth – only power and the quest to maintain it.” This is the underlying underpinnings of many societal constructs and organization. They are at their very essence of an entity created to seek its own welfare and the collective welfare of those who share its memberships. The postmodern feminist ideology holds that you must ‘identify these power structures through deconstruction and then to reverse those structures through political action (P. 36). There tools were useful because they were focused on oppression and as such useful and relevant to peoples who are marginalized everywhere.

I subscribe to the belief that feminist legal theories are a “house with many rooms.” I also argue that feminist legal theory use and borrow the best of other feminist theories. They are after all a fragmented constituency and with varying agendas and ends, often times lacking full cohesion. They have mastered the political process and it is baffling that while it appears they are closing the gap with men in terms of educational achievements and enrollment rates, they are still marginally represented in the workplace and in positions of power. This is a natural disconnect and should be a demonstrable sign that as a society we are still constricted to gendered roles. It shows that although women have made great strides they will always be jockeying for power and influence against a constituency bent on maintaining the status quo and thus control over them.

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The imbedded American notion…. Wed, 01 Apr 2009 23:48:44 +0000 more »]]> What will it be? The Blue or Red pill?

What will it be? The Blue or Red pill?

There is an imbedded American notion that the government and the three branches are the protector, arbiter and architects of the public good. The public assumes that if the FDA allows a regulated product on the market it is synonymous with a “good housekeeping” seal and declared safe. Not all regulated products undergo pre-market review; cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. This imbedded notion lacks “personal responsibility.”

This notion assumes that a government and its agents are driven by a desire to serve the public good without prejudice or viewing the public through their individual spheres and paradigms of beliefs or in some cases, simply what is political expedient. These paradigms and constructs are shaped by societal upbringing, education and one’s own internal sense of morality, justice, fairness and goodness. In this sense, who you are depends on where you are on the issue, and when you or someone you know is faced or affected by it. An individual’s belief and constructs are not time independent but entirely situational and contextual.

In The Structure of Scientific Revolutions (1962), Thomas Kuhn aptly wrote that “to understand scientific thought we must understand scientific communities; scientific knowledge changes, not as our understanding of the world changes, but as scientists organize and reorganize relations among themselves.” Equally important to understanding the biological, chemical and engineering challenges of medical products are the cultural, philosophical and regulatory challenges.

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Reflections on law and legal foundations….. Wed, 25 Mar 2009 03:33:21 +0000 more »]]> Reflections of law

Reflections of law

Among the various schools and paradigms of thought, it is difficult to assess where we are, without first exploring the history and purpose of food and drug law. The Federal Food, Drug & Cosmetic (FDCA) Act was the first comprehensive federal law regulating food and drugs. It was strictly an enforcement statute and designed to punish violations. It was born out of the problem with the current regulatory environment in 1933. Since it passage in 1938, there have been numerous amendments, both expanding and contracting its reach. There has also being challenges to relax and likewise tighten medical product regulation.

Eugene Bardach writes that “regulatory agendas are often said to become captured by the industry they regulate.” The agendas are also dictated by the legislative and executive branches of government. As history of food and drug law has thought us, you must have a tragedy, followed by public outrage, followed by new legislation or legislative authority. Instrumentalism/ functionalism and formalism structure the realm and basis of food and drug law in American society. One can argue that legal realism is at play, but that would require us to assume that the FDA is not a “Scientific” regulatory agency. The legal framework of Food & Drug Law is Administrative Law and thus concerned with both the rule and the legislative intent in adjudicating cases or promulgating regulations and guidance.

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The Policy Connection Mon, 23 Mar 2009 03:41:03 +0000 more »]]> The many facets of policy interactions....

The many facets of policy interactions….

In Foundations of the Law, Professor’s Bailey Kuklin and Jeffrey Stempel assert that “during its history, United States law has frequently resulted from commercial, geographic, social and political conflict” (1994:138). The regulation of medical products is no different; various perspectives apply to various constituents or stakeholders. Whether one is a patient, a medical practitioner, a developer of medical products “industry,” an academician, a legislator/regulator or a special interest entity, views are closely aligned by individual or collective interest, inherent philosophical beliefs, and conscious or unconscious ideologies and pedagogies.

The underlying construct for the regulation of food and drugs is in seeking a balance between prevention of harm vs. promotion of benefits and the public good. Finding the right balance shifts with political and societal changes over time. The political changes reflect the mandate of a party’s platform and have a direct bearing on what the overall “annual goals” would be. The societal changes can be political, economic, social, and technological or scientific/ technological advancements. What makes administrative law unique and has regulatory agencies in a conundrum is that they are ultimate responsible to everyone and have a perceived duty to be balanced. They are responsible to congress, the judiciary, legislators, the executive branch, industry, special interests and the public at large. Regulatory agencies are ultimately in a battle for legitimacy and this takes a toll on resources and indeed agency morale.

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