The Food and Drug Administration needs more resources for oversight of products developed and manufactured overseas, FDA Commissioner Dr. Margaret Hamburg said during a House hearing examining the Prescription Drug User Fee Act.

During the hearing, Hamburg addressed questions from Reps. Joe Pitts (R-Pa.) and Jan Schakowsky (D-Ill.) about the FDA's oversight of drug companies that manufacture products or active pharmaceutical ingredients outside of the U.S. Up to 65% of clinical trials for FDA-regulated products occurred outside of the U.S.

“We need additional resources to provide the level of oversight that we think is necessary and appropriate,” Hamburg said, in response to a question from Schakowsky about the oversight of clinical trials conducted overseas.

She also discussed industry concerns about conflict-of-interest rules for advisory committee members. Reps. Frank Pallone Jr. (D-N.J.) and Phil Gingrey (R-Ga.) asked Hamburg whether waiver caps allowed the committees to be adequately staffed by qualified members; she said that while the conflict-of-interest rules had gotten “thornier,” she does not support a legislative fix.

The FDA can grant a waiver for some conflicts of interest. If not, an advisory committee member with a financial interest in an issue is required to withhold his or her vote and be excluded from discussions about the issue. There is a cap on the number of waivers that the FDA can grant.

Supply chain issues, including drug shortages and a national drug pedigree, were also brought up. Deborah Autor, FDA's deputy commissioner for global regulatory operations and policy, said the implementation of a national pedigree may require action from Congress.

Drug pedigrees are documents that track a product from the manufacturer to the final buyer in order to ensure the integrity of the supply chain. Autor said it is unclear to the FDA whether a national pedigree would pre-empt state laws—29 states have pedigree laws in effect—or whether the current laws would be binding for all the companies involved.

Last month, the FDA provided recommendations to Congress about the reauthorization of the prescription drug user-fee program as well as recommendations for proposed generic-drug and biosimilars user-fee programs. The FDA and drug industry work collaboratively to develop the terms of the user fees, which are then used to support the agency's drug approval processes. Reauthorization is required every five years.

On Wednesday, the FDA said it reached an agreement in principle with the device industry on the medical device user-fee program although it has not yet provided the recommendations to Congress.

Executives from the American Academy of Pediatrics, the Biotechnology Industry Organization, the California Healthcare Institute, the National Organization of Rare Disorders, the Pew Health Group, Pfizer and PhRMA testified during the second half of the hearing.