The Complete Pharm Exec Guide to PDUFA - Pharmaceutical Executive

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The Complete Pharm Exec Guide to PDUFA
What Congress's grand plans for the "revitalization' of FDA really mean...besides more red tape


Pharmaceutical Executive


10 Citizen Petitions

Both bills include provisions seeking to limit delays in the approval of generic applications due to Citizen Petitions, submissions to the agency—typically by innovator companies—putting new scientific data and legal arguments before the agency for review. While Citizen Petitions have been criticized as a tool to delay competition, many submissions have brought critical scientific information and safety concerns to agency attention. Both bills seek to mandate approval timelines and final agency action in response to petitions, although the Senate bill permits an exception for delays that are necessary to protect the public health.

11 Reagan-Udall Foundation

The House and Senate adopted identical language establishing a public–private foundation to lead collaborations to support FDA's mission. Such collaborations would be focused on Critical Path activities, including boosting R&D productivity and making product development and safety more predictable and manageable. Although some funding for the foundation could come from FDA appropriations, the bills contemplate that funding largely will be provided by industry and philanthropies.

12 Antibiotics and Enantiomers

The Senate bill includes language that would expand exclusivity for certain forms of older antibiotics with a new dosage form or a new indication. Sponsors of antibiotics approved before November 21, 1997, may be granted three-year exclusivity, while sponsors of an application submitted, but not approved, before November 21, 1997, are eligible to receive three or five years of exclusivity, as applicable, or a patent-term extension. Other Hatch-Waxman provisions (except other exclusivity provisions) apply.

Under conditions where approval is sought for new therapeutic categories relying on full clinical studies, the Senate bill would also permit Hatch-Waxman exclusivity for non-racemic drugs containing as an active ingredient a single enantiomer also contained in a racemic drug. The House bill does not contain a corresponding provision.

13 Importation and Anticounterfeiting

The Senate bill contains a provision allowing for drug importation from certain countries but requires FDA to certify that implementation of drug importation will "(1) pose no additional risks to the public's health and safety and (2) result in a significant reduction in the cost of covered products to the American consumer." The House bill does not include an importation provision.

The Senate importation certification requirement would not affect the bill's anticounterfeiting measures. The Senate bill would require a standardized numerical identifier unique to each drug package, harmonized with international consensus standards and applied at the point of manufacturing and repackaging. It would also require, for the 50 prescription drugs with the highest US sales, optically variable counterfeit-resistant technologies that could be seen with the naked eye, similar to what is used to secure US currency. These drugs must be manufactured and distributed in a secure and controlled environment, and they must include additional nonvisible features within two and a half years of enactment. The bill would also allow for the use of other technologies with a comparable security function.

The House bill also promotes anticounterfeiting, yet adopts a more realistic approach by calling for the development of standards and validated technologies for effective implementation.

14 The Biosimilar Debate

A wild card in PDUFA IV is whether to authorize the approval of biosimilars, or generic biologics. Various factors, including the relatively smooth development of the FDA "revitalization" amendments, have led to bipartisan cooperation and progress on the issue in both houses of Congress. Although critical flaws remain to be addressed, the current Senate biosimilars legislation, S. 1695, is somewhat closer to a compromise than many believed was possible given the contentious nature of the debate. The process has been more heated in the House, with a number of key members opposing the inclusion of biosimilars legislation in the conference negotiations, citing open scientific and legal issues and a lack of consideration in House committees. It remains to be seen whether the gap between the sides can be bridged in time for PDUFA IV to include biosimilars authorization. If not, many believe the issue will be pressed as part of other legislation this session.


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