Vol. 1, No. 12: How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?

How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?

Seth B. Whitelaw

Whitelaw discusses the changes to financial disclosure regulations following the passage of the Patient Protection and Affordable Care Act. The new transparency requirements created by the Act are out of sync with FDA’s existing regulations, and Whitelaw explains that this could lead to increasing cost for manufacturers.

The author specifically recommends that FDA should:

• Require disclosure of payments to institutions in addition to investigators.
• Set reportable limits based upon annual compensation received during a calendar year, establish unambiguous points for the beginning and end of a study and allow applicants to cross-reference data in disclosures made under the new PPACA sunshine provisions.
• Enforce the disclosure provisions when breached.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1 No. 11: Did FDA Apply a Remedy Worse than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena?

Did FDA Apply a Remedy Worse than the Disease in Refusing to Clear the Market of Unapproved Versions of Makena?

Sheldon T. Bradshaw, Partner, Hunton & Williams LLP

Kyle Sampson, Partner, Hunton & Williams LLP

Brian J. Wesoloski, Associate, Hunton & Williams LLP

The authors discuss the unapproved (compounded by pharmacists) versions of Makena that remained available after FDA approval and express concern that the agency did not take enforcement action against these drugs.

The authors specifically recommend that FDA should:

• Publicly acknowledge that its decision not to take enforcement action against pharmacies marketing unapproved versions of Makena was erroneous and reverse that decision.
• Reaffirm its long-standing position that “traditional pharmacy compounding” does not include the compounding of commercially available drug products.
• Advise consumers to avoid compounded drug products when an FDA-approved product is available.
• Clear the market of unapproved drug products that undermine 1) the value of ODA exclusivity and 2) the incentives to study orphan drug indications.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1, No. 10: How Can the Federal Government Prevent Some Tobacco Product Manufacturers from Evading Taxes and Avoiding FDA Regulation?

How Can the Federal Government Prevent Some Tobacco Product Manufacturers from Evading Taxes and Avoiding FDA Regulation?

Anne D. Spiggle, Associate, Patton Boggs LLP

Spiggle identifies problems in tobacco regulation that have appeared in the wake of the Family Smoking Prevention and Tobacco Control Act. Her concern is with tobacco manufacturers who mislabel their products in order to avoid both federal excise taxes and the requirements of the Food and Drug Administration’s (FDA’s) tobacco regulation. Spiggle explains that this endangers public health and allows manufacturers to sell misbranded products at low prices.

The author specifically recommends that:

• The Alcohol and Tobacco Tax and Trade Bureau should use its authority under the existing tax code to enforce the correct federal excise tax rate on “filtered cigars” and “pipe tobacco.”
• FDA should immediately exercise its existing enforcement authority to regulate “filtered cigars” and “pipe tobacco” for what they are—cigarette substitutes and roll-your-own cigarette tobacco—and require these products to comply with the Federal Food, Drug and Cosmetic Act.
• Congress should revise the Internal Revenue Code’s definitions of cigars and pipe tobacco in order to close the door that gives rise to the intentional mislabeling of tobacco products.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1, No. 9: Should Congress Pass Legislation to Regulate Child-Directed Food Advertising?

Should Congress Pass Legislation to Regulate Child-Directed Food Advertising?

Roseann B. Termini, Professor, Widener University School of Law

Thomas A. Roberto, 2011 J.D. Candidate, Widener University School of Law

Shelby G. Hostetter, 2011 J.D. Candidate, Widener University School of Law

In the wake of the Interagency Working Group on Food Marketed to Children’s release of proposed principles, the authors examine the issue of advertising as it relates to childhood obesity. Concerned with the current lack of regulation in this area, the authors recommend that manufacturers become more involved in fighting obesity.

• Enforce corporate accountability measures for the implementation of internal policies by food manufacturers that advertise to children.
• Eliminate food advertising as an ordinary business expense for tax purposes, provide incentives for healthy messages and include "commercial-free time zones."
• Utilize the FTC, FDA, CDC and USDA marketing experts' Interagency Working Group Proposal on Food Marketing to Children.
• Encourage alternative solutions to regulation, including adult involvement.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1, No. 8: Will the FDA Food Safety Modernization Act Level the Playing Field Between Domestic and Imported Foods?

Will the FDA Food Safety Modernization Act Level the Playing Field Between Domestic and Imported Foods?

Robert A. Hahn, Olsson Frank Weeda Terman Bode Matz PC
Hahn provides a detailed account of the new import regulations created by the Food Safety Modernization Act (FSMA). “The FSMA goes a long way towards leveling the regulatory playing field between domestic and imported foods, but perhaps inevitably establishes different enforcement mechanisms for domestic and imported products.” Concerned about the burdens that FSMA places on FDA and U.S. importers, Hahn suggests spreading the new responsibilities among third party auditors and foreign government agencies as well as U.S. authorities.

The author specifically recommends that FDA should:

·         Leverage inspections by foreign government agencies and audits by accredited third party auditors to extend FDA’s reach overseas.

·         Use the new enforcement tools at FDA’s disposal to exclude problem importers and foreign processors from access to the U.S. market.

·         Avoid placing unrealistic burdens on U.S. importers, such as requiring them to verify upstream suppliers beyond their immediate foreign suppliers.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1, No. 7: Should Congress Amend FDCA To Create Earlier Patient Access to New Treatments for Serious and Life-Threatening Conditions?

Should Congress Amend FDCA To Create Earlier Patient Access to New Treatments for Serious and Life-Threatening Conditions?

Steven T. Walker, Co-Founder, Abigail Alliance for Better Access to Developmental Drugs

Walker explains that “timely approval and access to investigational drugs has been strictly limited by FDA, rendering the agency a powerful protector of the 50-year-old clinical trials system—a system now broadly perceived as failing and obsolete.” He suggests an updated clinical trial system that will allow patients safe and quick access to new drugs.

The author specifically recommends that Congress should:

·         Create the statutory flexibility needed for establishing new medical treatment development concepts and approval standards that are better aligned with advancing scientific knowledge and medical innovation by updating the approval standards set forth in the Federal Food, Drug and Cosmetic Act.

·         Establish a transparent congressional annual review process to assess the state of FDA’s scientific performance, with the goal of ensuring that its regulatory science catches up and keeps pace with advancing biomedical science.

·         Create a new drug approval pathway and improve investigational drug access mechanisms to complement FDA’s efforts to characterize the safety, efficacy and targeting of new treatments while simultaneously addressing the unmet needs of patients.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

Vol. 1, No. 6: Should FDA Restructure Its Drug Review Process?

Should FDA Restructure Its Drug Review Process?
Scott Gottlieb, Fellow, American Enterprise Institute

Gottlieb explores the issue of disagreement among FDA’s Center for Drug Evaluation and Research scientific staff, which he calls disruptive to the drug review process. According to Gottlieb’s analysis, FDA groups scientists in ways that prevent cooperative interaction. He specifically recommends a reorganization of review staff, grouping personnel by areas of therapeutic focus rather than scientific discipline.

The author specifically recommends that FDA should:

• Group more of its review staff around areas of therapeutic focus rather than scientific discipline to prevent fragmentation of its scientific staff.
• Organize review staff based on a matrix that is focused around projects rather than review functions in order to foster more scientific collaboration.
• Create an Office of the Chief Medical Officer as part of the drug review structure, to mediate conflicting opinions between review staff.
• Assemble review teams that work on multiple projects and build cohesion across several reviews, rather than rely on temporary work groups that are brought together for each individual application.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.