Volume 51 Issue 2
FDLI has initiated a policy regarding the Food and Drug Law Journal online: Only the Table of Contents and article abstracts for each issue will be posted to our website. Visitors can obtain a full text version of an entire issue. Your purchase will be processed quickly, and at reasonable rates.
Any questions or concerns regarding this policy should be directed to
Michael Levin-Epstein, FDLI's Editor-in-Chief.
Table of Contents
> Remarks by the Commissioner
of Food and Drugs
> Corporate Compliance Audits
> The FDA's Reaction to Corporate
Compliance Audits
> Corporate Compliance Programs
for FDA-Regulated Companies: Incentives for Their Development
and the Impact of the Federal Sentencing Guidelines for Organizations
> Regulation of Cosmetics That
are Also Drugs
> Second Thoughts: Do the FDA's
Responses to a Fatal Drug Trial and the AIDS Community's Doubts
About Early Access to Drugs Hint at a Shift in Basic FDA Policy?
> GATT Implementation and Generic
Drug Approval
> A Sad Story Told Sadly: The
Prospects for U.S.-EU Food Trade Wars
> FDA Regulation of Ingredients
in Dietary Supplements After Passage of the Dietary Supplement
Health and Education Act of 1994: An Update
> Regulating Dietary Supplement
Safety Under the Dietary Supplement Health and Education Act:Brave
New World or Pyrrhic Victory?
> Constitutional Protection
of Commercial Speech Under the Central Hudson Test as Applied
to Health Claims
> Forces Reshaping the Performance
and Contribution of the U.S. Medical Device Industry
> The Use of Standards is the
Name of the Game
> The U.S. Medical Device Industry:
Entrepreneurs' Future Hinges on Reforms at the Food and Drug
Administration
Remarks by the Commissioner of Food and Drugs
Author: David A. Kessler
Issue: 51 Food and Drug Law Journal 207-216 (1996)
Three new studies show that the Food and Drug Administration (FDA) is reviewing new drug and biologics applications in record time, and that patients in the United States have access to equivalent versions of major pharmaceuticals as soon as, if not sooner than, patients in other major industrialized nations. In a report to Congress required under the Prescription Drug User Fee Act of 1992 (PDUFA), the FDA reported that for new drug and biologics applications submitted in fiscal year 1994 — the latest year for which there is complete information under PDUFA — the agency reviewed and acted on ninety-six percent of the applications on time, well above PDUFA performance goals. In an international comparison with drug review systems in the United Kingdom (UK), Germany, and Japan, it was shown that drugs become available in the United States as fast as, or faster than, in those other countries. A third study, conducted by the General Accounting Office, found that the FDA's drug approval times had decreased by forty-two percent from 1987 to 1992, the years before PDUFA, and that a direct comparison with the UK found the FDA to be just as fast, or faster, in reviewing and approving new pharmaceuticals. The reports demonstrate conclusively that there is no drug lag in this country.
| Back to top |
Corporate Compliance Audits
Author: George M. Burditt
Issue: 51 Food and Drug Law Journal 217-220 (1996)
Legal and ethical responsibilities are leading many companies to conduct audits of their operations to ensure compliance with all applicable federal and states statutes, to reduce product liability risks, and to avoid increased penalties under the Federal Sentencing Guidelines. This article explains the rationale for such audits, defines their scope, and describes how they should be conducted.
| Back to top |
The FDA's Reaction to Corporate Compliance Audits
Author: Arvin P. Shroff
Issue: 51 Food and Drug Law Journal 221-224 (1996)
Corporate compliance audits, if properly implemented, can be a saving force, not only in maintaining and/or improving the quality of products, but also in product liability and demonstrating a good compliance record. The emphasis is on preventing errors rather than detecting them restrospectively. Serious deficiencies or problems are manifested when attention to quality is slighted or ignored. Compliance requires dedication by top management, support and commitment by middle management and supervisors, and a thorough understanding by employees as to what is expected. This article offers a basic outline of steps a company should consider when crafting an audit system.
| Back to top |
Corporate Compliance Programs for FDA-Regulated Companies:
Incentives for Their Development and the Impact of The Federal Sentencing Guidelines for Organizations
Author: Dana H. Freyer
Issue: 51 Food and Drug Law Journal 225-242 (1996)
In 1991, the U.S. Sentencing Commission issued Guidelines governing the sentencing of corporations and other organizations found to violate certain federal crimes. The Guidelines considerably increase the penalties for such violations and also permit a substantial reduction in the penalties imposed on an organization if, at the time of such offense, it had "an effective program to prevent and detect violations of law." The Guidelines are only one facet of the current corporate and regulatory environment that has caused companies — especially those in the food and drug industry — to evaluate the adequacy and effectiveness of their compliance programs. For example, there has been a notable increase in criminal prosecutions against pharmaceutical and health care companies. In addition, the government has required the implementation of compliance programs as part of the relief imposed against a number of companies. Moreover, the Food and Drug Administration recently expressed increased concern over a "corporate culture of poor compliance practices." This article discusses these and other incentives for developing compliance programs and how best to structure them.
The starting point for structuring a compliance program that will survive the scrutiny of the courts and federal agencies are the seven due diligence steps set forth in the commentary to the Guidelines. Although the commentary identifies the general requirements of an effective compliance program, each program must be tailored to the individual company's culture, organization, legal concerns, and history; compliance program must change as the organization changes or as the legal and/or regulatory requirements change.
| Back to top |
Regulation of Cosmetics That Are Also Drugs
Author: Jacqueline A. Greff
Issue: 51 Food and Drug Law Journal 243-272 (1996)
Cosmetics in the United States are subject to minimal regulation, whereas drugs are regulated pervasively. The Federal Food, Drug, and Cosmetic Act defines cosmetics and drugs based on their intended use. Products intended for use as both cosmetics and drugs are subject to both sets of requirements. Tension exists as industry attempts to avoid expensive, burdensome drug regulation while the Food and Drug Administration (FDA) works to protect the public by enforcing drug safety and efficacy requirements. The FDA's approach has evolved from using overt claims to classify cosmetics as drugs, to looking at a cosmetic's ingredients and physiological effects as indicia of manufacturer intent. The latter classification process has not been entirely consistent across product categories and occasionally pushes the limits of statutory authority.
| Back to top |
Second Thoughts: Do the FDA's Responses to a Fatal Drug Trial and the AIDS Community's Doubts About Early Access to Drugs Hint at a Shift in Basic FDA Policy?
Author: Matthew C. Lovell
Issue: 51 Food and Drug Law Journal 273-294 (1996)
In June 1993 a promising clinical trial of FIAU, an experimental drug to treat hepatitis B, came to a sudden and tragic close. Five out of the ten subjects undergoing Phase II studies fell ill and died over several weeks. A Food and Drug Administration (FDA) task force determined that the investigators, flush with success in treating the elusive disease, had ignored signs of the underlying toxic processes that led to the deaths. As a result of these findings, the FDA proposed regulations to greatly expand researchers' and manufacturers' duties to report adverse events that occur during testing and after the approval of new drugs. At the same time, influential AIDS activists were urging the FDA to compel more rigorous testing of experimental AIDS drugs. This development contrasted strongly with prior demands for early, broad access to drugs and the FDA's rapid responses thereto.
While the proposed regulations and the new voices advocating caution in drug testing are significant, they do not foretell a basic shift in recent FDA policy. The proposed regulations were criticized soundly during the public comment period, and they have been held in abeyance and threatened both by proposals for regulatory reform and by demands for increased congressional oversight of the FDA. Furthermore, the trend toward streamlining the review process for new drugs is now quite deeply embedded in the Code of Federal Regulations and in the consciousness of the public.
| Back to top |
GATT Implementation and Generic Drug Approval
Authors: Peter O. Safir & Scott M. Lassman
Issue: 51 Food and Drug Law Journal 295-302 (1996)
The General Agreement on Tariffs and Trade 1994 (GATT), as implemented by the Uruguay Round Agreements Act (URAA) has had a profound impact on the approval of abbreviated new drug and section 505(b)(2) applications. This has been one the most hotly litigated issues in the area of food and drug law in the past year, pitting pioneer drug companies against generic drug makers, the Food and Drug Administration (FDA), and even the Patent and Trademark Office (PTO). Now that the dust mostly has settled on the judicial battlefield, it is clear that the pioneer companies have won every major legal conflict over the meaning and implementation of the URAA, with one conspicuous exception. This article will analyze the controversy as well as the recent caselaw that is defining the interaction between the URAA and the generic drug approval process.
| Back to top |
A Sad Story Told Sadly: The Prospects for U.S.-EU Trade Wars
Author: Charles Lister
Issue: 51 Food and Drug law Journal 303-312 (1996)
Trade wars are welcomed by virtually no one, and yet they remain a recurrent fact of economic life. The reasons are many: the low priority given to harmonization of the rules governing food products, partly different regulatory approaches and philosophies in the United States and the European Union (EU), different economic and political pressures on each side of the Atlantic, and different institutional constraints. In many cases, food products may be the victims of trade wars actually related to entirely different products; restrictions on imports of foreign foodstuffs may be used as a basis for retaliation.
This article reviews the principal causes of trade disputes between the United States and the EU regarding food products, and describes the areas in which they seem most likely to arise. It predicts that such disputes are likely, although not inevitable, and urges greater and more consistent efforts on both sides of the Atlantic to understand one another's problems and constraints, and to seek a more harmonized approach to regulatory and trade issues.
| Back to top |
FDA Regulation of Ingredients in Dietary Supplements After Passage of the Dietary Supplement Health and Education Act of 1994: An Update
Author: Stephen H. McNamara
Issue: 51 Food and Drug law Journal 313-318 (1996)
This article reviews the regulatory requirements for ingredients in dietary supplement products, as enforced by the Food and Drug Administration (FDA), now that the Dietary Supplement Health and Education Act of 1994 (DSHEA) has been enacted. This review includes some legislative history of the Act, a discussion of the expanded definition of "dietary supplement," and an explanation of the changes in regulatory requirements for the use of dietary supplement ingredients. These changes have been brought about by modifications to the ingredients' safety standard and by procedural modifications that have moved the regulatory process from one of preclearance to one of policing.
| Back to top |
Regulating Dietary Supplement Safety Under the Dietary Supplement Health and Education Act:
Brave New World or Pyrrhic Victory?
Author: Bruce A. Silverglade
Issue: 51 Food and Drug Law Journal 319-322 (1996)
The Dietary Supplement Health and Education Act of 1994's (DSHEA's) approach to dietary supplement ingredient regulation ultimately may lead to a decreased consumer confidence in the safety of supplements and a possible loss of credibility for the industry. As a result, the DSHEA may turn out to be a "pyrrhic victory" for the dietary supplement industry, and food companies should be hesitant to embrace it as a model for reform.
| Back to top |
Constitutional Protection of Commercial Speech Under the Central Hudson Test
as Applied to Health Claims
Author: Marilyn J. Schramm
Issue: 51 Food and Drug Law Journal 323-330 (1996)
Despite a confusing collection of Supreme Court cases addressing the commercial speech doctrine in recent years, the original Central Hudson four-part test, set forth in 1980, was reaffirmed explicitly in Rubin v. Coors Brewing Co. Careful consideration of Justice Powell's explication in Central Hudson of the test's fourth prong, together with insight provided by a recent commentator, leads to the conclusion that the Food and Drug Administration's (FDA's) health claims regulations would not withstand constitutional scrutiny under a First Amendment challenge.
The FDA's regulations prohibit some health claims that merely have the "potential" to mislead. Central Hudson and other Supreme Court cases require disclosure (or counterspeech), rather than an outright ban, to address potentially misleading commercial speech. A carefully brought First Amendment challenge to the FDA's regulations on health claims would, therefore, likely be successful.
| Back to top |
Forces Reshaping the Performance and Contribution of the U.S. Medical Device Industry
Author: James S. Benson
Issue: 51 Food and Drug Law Journal 331-336 (1996)
A survey conducted by The Wilkerson Group, Inc. reveals that the U.S. medical device industry is undergoing radical change. Numerous public and private sector forces are dramatically increasing the cost of product development and commercialization, altering access to markets and financing, and causing the industry to adapt, refocus, and reallocate its resources. The forces affecting the industry include an overly burdensome regulatory process, increased pressure to contain health care costs, an increasingly litigious environment, more restrictive reimbursement policies, and diminishing venture capital funds. In their attempts to remain competitive, growing numbers of U.S. medical device manufacturers are moving clinical trials and manufacturing facilities offshore. Research and development dollars, as well as new product introductions, are following in their wake. Together, these public and private forces threaten the high quality of health care long enjoyed by patients in the United States. U.S. patients often receive the latest advances in medical technology months, even years, later than patients in other countries. This reflects lost opportunities to save lives, reduce hospitalization costs, and improve patient quality of life.
| Back to top |
The Use of Standards is the Name of the Game
Author: Philip B. White
Issue: 51 Food and Drug Law Journal 337-338 (1996)
For the past eight years both the U.S. government and the medical device industry have increased their involvement in the development of standards. They have been particularly involved in developing international standards, primarily because of the European Union's (EU's) creation of a single internal market that has one system for regulated products such as devices. The EU system is based on the use of standards to demonstrate compliance with European Directives that legally define essential requirements. In the United States and throughout the world, efforts are underway to utilize international standards, especially those based on the ISO 9000 quality management standard. The medical device good manufacturing practice regulations are being revised to incorporate provisions of ISO 9000. This article describes some policy measures being taken that signify the importance of using standards to demonstrate compliance with regulatory requirements in the United States and around the globe.
| Back to top |
The U.S. Medical Device Industry: Entrepreneurs' Future Hinges on Reforms
at the Food and Drug Administration
Author: Jeffrey J. Kimbell
Issue: 51 Food and Drug Law Journal 339-344 (1996)
This article presents the viewpoints of some medical device manufacturer associations regarding recent congressional efforts to reform the device approval process and to effect change in various enforcement policies of the Food and Drug Administration. The article calls for the active involvement in the reform effort by Congress, federal agencies, device industry officers and employees, health care practitioners, patient populations, and the public at large. Possible legislative initiatives and major recommendations for reform are discussed, and the article concludes that the United States cannot afford the status quo to continue in this area.
| Back to top |