Supply Chain Security Issues To Emerge During Subcommittee Hearing On PDUFA

The Pharmaceutical Research and Manufacturers of America will push to require registration of foreign manufacturing facilities making prescription drugs for the U.S. market during a Feb. 1 House Energy and Commerce Health Subcommittee hearing.

The idea, intended to help strengthen supply chain security, resembles a provision in the pending generic drug user fee agreement. It also could rekindle debate over implementing a foreign inspection fee for prescription drug manufacturers.

The subcommittee hearing was scheduled to talk about the reauthorization of the Prescription Drug User Fee Act, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. It also will include supply chain issues.

David Wheadon, senior vice president of scientific and regulatory affairs, will testify on behalf of PhRMA.

Written testimony posted by the subcommittee indicates PhRMA will call for a requirement that foreign manufacturing facilities identify themselves to FDA if they make products or components for the U.S. market as well as provide a list of what they produce.

“By requiring such facilities to register, the FDA will be able to establish a single database that will contain information on all facilities that manufacture products or components of products that are sold in the U.S.,” according to PhRMA.

The group said in an e-mailed statement it wants Congress to give FDA discretion to use its resources to target inspections using a risk-based approach. It did not mention whether user fee revenue should be used specifically to create the database.

FDA’s agreement with the generic industry for a generic drug user fee includes a requirement for all foreign finished dosage form and active pharmaceutical ingredient manufacturers to register with the agency.

That database is intended to help determine how much each facility will pay in fees. Both sides agreed to a fixed amount of user fee revenue that will be collected each year and a defined percentage will come from facility fees in the GDUFA proposal.

The more facilities that register with FDA, the less each will pay, giving industry an incentive to register as many facilities as possible. Data collection is expected to begin this fall (Also see "Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation" - Pink Sheet, 19 Dec, 2011.).

GDUFA facility fees will support increased agency manufacturer inspections, particularly outside the U.S.

Expanding prescription drug facility registration beyond current law, particularly if user fee revenue is used, could be seen as a step toward eventually including foreign inspection fees in PDUFA.

Facility and inspection fees were not part of PDUFA negotiations, but the GDUFA agreement could be a test run for such an idea (Also see "Is Silence Golden For Brand Companies On Inspection Fees?" - Pink Sheet, 4 Apr, 2011.).

FDA’s foreign inspection burden is growing and the agency is looking to create coalitions of foreign regulators to potentially share inspection and other information. The coalitions could help the agency better target its resources (Also see "FDA Envisions Many Regulatory Coalitions Dealing With Globalization Issues" - Pink Sheet, 26 Sep, 2011.).

A supply chain security bill proposed by Rep. John Dingell, D-Mich., at one time included a facility inspection fee, but it was removed. During a Senate hearing on PDUFA in September, PhRMA evaded a question about whether it would accept inspection fees (Also see "Inspection Fees For Drug, Ingredient Manufacturers Could End Up In PDUFA, Sen. Harkin Says" - Pink Sheet, 14 Sep, 2011.).

BIO To Call For National Track And Trace Standard

The Biotechnology Industry Organization will call for a national track and trace standard for the domestic supply chain in its testimony, an issue that seems to have gained some favor on Capitol Hill already.

The trade group will say that Congress should create one standard rather than expect the states to enact their own laws. The system would standardize efforts nationwide, according to BIO.

“Such an approach would enable the identification and adoption of a consensus and technology-neutral standard for a traceability system achieved through a progressive process where each system advancement is predicated upon clearly defined triggers and benefits analysis,” Richard Pops, chairman and CEO of Alkermes PLC, will tell the House panel on BIO’s behalf.

FDA is designing track and trace standards and could release them shortly. Infrastructure for a system has not been determined yet, but models are being considered, the agency says (Also see "Track and Trace Standards Coming Shortly, FDA Says" - Pink Sheet, 2 Jan, 2012.).

BIO also will push for biosimilars to have unique names rather than share the innovators’ names during the debate about how to structure the new biosimilar approval pathway. The group will argue that not having distinguishable names could lead to inadvertent substitution and hinder adverse event tracking.

FDA seemed interested in requiring unique names in order to track AEs effectively during a 2010 hearing on implementing the pathway (Also see "FDA Signals Interest In Requiring Unique Biosimilar Names" - Pink Sheet, 2 Nov, 2010.).

Generic, Biosimilar User Fee Hearing Planned

The subcommittee hearing will be the first since FDA formally delivered the completed PDUFA reauthorization agreement with industry to Congress.

FDA Commissioner Margaret Hamburg will testify first. Her testimony had not been posted as of Tuesday afternoon.

The National Organization for Rare Disorders, Pew Charitable Trusts and American Academy of Pediatrics also will testify as part of a seven-witness panel following Hamburg.

The subcommittee scheduled a hearing Feb. 7 to address drug shortages and the completed agreements for the generic drug and biosimilar user fees.

Janet Woodcock, director of the Center for Drug Evaluation and Research, is scheduled to testify, but no other witnesses have been announced (Also see "PDUFA V Action Heats Up On Hill With House Hearings In February" - Pink Sheet, 12 Jan, 2012.).