US Senate Opens Hearings on PDUFA Reauthorization, Drug Pedigree Mandate

Congressional committees are now talking about reviving track-and-trace legislation, after numerous bills alluding to it were introduced during the current session. It has long been rumored that Congress would roll this legislation into the hearings for reauthorization of the Prescription Drug User Act (PDUFA), which is essential to the ongoing functioning of FDA and must be reauthorized by October 2012 (a parallel program for generic user fees is also in progress). In an opening statement, Health, Education, Labor and Pensions chair Senator Tom Harkin (D, IA) said that “We must have an honest conversation about how globalization impacts the integrity of our drug supply and what must be done to ensure our safety.” Ranking minority member, Senator Mike Enzi (R, WY) said, “We all want to make sure FDA has the tools it needs to ensure supply chain security. At the same time, I am concerned about FDA over-regulating in a way that threatens jobs and patient access to therapies.”

PDUFA is a complex and expensive program for the pharma industry, dictating the cost and timetable for reviewing and approving new drugs. The extent to which supply chain security issues will become part of the legislation is still in question, but the last time Congress passed legislation on FDA operations (the FDA Amendments Act of 2007), it included requirements for FDA to continue to advance the subject—but falling short of instructing FDA to actually implement it. When California amended its statewide e-pedigree legislation in 2008, it specified a 2015 deadline for manufacturers to begin providing item-level identification of drug products, and a 2017 deadline for that program to be fully implemented at retail outlets, for an end-to-end track-and-trace system. (California also stipulated that its program would defer to any federal program—essentially pushing the feds to take over—which is something that most in industry want in order to avoid having 50 states with 50 different pedigree requirements.)

At the hearing, the supply-chain security discussion was dominated by comments on FDA’s fading ability to secure the integrity of APIs and finished products manufactured abroad—essentially, the front end of the pharma supply chain. (While several nations have started up programs to serialize drug products for internal use, there is to date no effort to organize a global track-and-trace system.)

Legislative goals

In her testimony, Deborah Autor, FDA deputy director for global regulatory operations, listed 12 legislative actions the agency is seeking from Congress:

1. Refusal of drug imports if overseas facility inspections have been hampered or denied 2. Refusal of drug imports if the shipment lacks compliant or certification information 3. Requiring quality management systems for ingredient manufacturers 4. Mandatory (as opposed to the current, voluntary) recall authority 5. “Administrative destruction at the border”—the ability to destroy, rather than simply reject, noncompliant product, which shippers could otherwise attempt to be reimport 6. Detention of illegal drugs—which is in place for FDA for food and medical devices, but not drugs 7. Enhanced criminal and civil penalties for serious health violations 8. Modernization of drug registration and listing to ensure accurate information about suppliers 9. Mandated notifications to FDA when known counterfeits, thefts or other improper conditions exist for drugs in the supply chain 10. Unique facility identifiers as a condition of import, to enable FDA inspectors and recordkeepers to keep track of risks 11. Authority to share certain non-public information with other regulatory agencies 12. Track-and-trace: “Requiring a cost-effective track-and-trace system for all drug products throughout the supply chain would improve the security and integrity of the drug supply.”

Given this long list (and given how a severely divided Congress will look not only on new regulatory authority for a federal agency, as well as the question of pre-empting state programs by one emanating from Washington), it is uncertain how far the track-and-trace legislation will progress. Industry testimony at the hearing was supportive of improving overseas inspections of facilities, but guarded on track-and-trace. “GPhA also recommends that Congress adopt a federal pedigree system . . . setting a reasonable, uniform standard. The challenge to implementation will be to ensure that the technology is reasonable and feasible in light of numerous economic, technical and logistical factors so that the end product does not result in an increase to consumer and payer cost,” said Gordon Johnston, a senior advisor at GPhA. PhRMA ducked the topic in its prepared testimony.

In submitted comments, the National Community Pharmacists Assn. (www.ncpa.net) CEO B. Douglas Hoey said, “NCPA continues to feel that track and trace technologies remain largely unproven and such a system may prove to be prohibitively expensive for independent community pharmacies,” but offered some recommendations: A risk-based approach should be taken rather an across-the-board requirement for all drug shipments; that federal grants should be provided to community pharmacies; and that any system adopted should be interoperable among manufacturers and distributors. Additionally, the use of “inference”—a means of checking carton-size shipments, rather than individual packages—should be allowed, and pilot projects should be undertaken prior to any mandated implementation.