House FDA Hearing: No Plan for Domestic Drug Manufacturing

Last week, a hearing by the House subcommittee on health inside the Energy and Commerce Committee didn’t turn out any headlines for domestic drug manufacturing as it focused on 22 bipartisan bills centered on drug trials and accelerated applications for cancer drugs. There was no mention of domesticating local supply chains, and very little talk about Generic Drug User Fee Amendments, or GDUFA, which a handful of witnesses urged be re-authorized before the September deadline.

Generic drugs and supply chains were not mentioned in the opening statement by Subcommittee on Health Chairwoman Anna G. Eshoo.

Energy and Commerce Committee chairman Frank Pallone Jr. only mentioned generic drugs in his opening remarks in a brief highlight of H.R. 7032 by Rep. Annie Kuster (D-NH-2), saying her bill would “simplify the process for generic manufacturers and reduce needless delays, bringing generic competition to market more quickly.”

The 22 bills that were highlighted on Thursday might become part of the three separate user fee authorization bills for the Food and Drug Administration. These reauthorizations set part of the budget for the FDA to do inspections and handle new drug applications. These fees are paid for by the industry.

The fees are predetermined by FDA and industry in closed-door meetings in the years leading up to the reauthorization. The fees are reauthorized every five years. Congress has never actually determined what the fees should be for manufacturers. In past reauthorizations, foreign facilities paid slightly more – that was eventually amended to put foreign facilities on par with domestic producers and now they’re all the same. Congress often uses this reauthorization as a way to put in place policy riders that impact the industry and patient access.

One might expect this year’s reauthorization to be a bit different. After all – we had a two-year pandemic that exposed America’s vulnerable supply chain for medicine – and over the last twenty years, we have seen a hollowing out of generic manufacturing capacity.

Yet, no one discussed this in the hearing last week, suggesting it was not a major component of any of the 22 bills.

Rep. Buddy Carter said that there is a difference between “recognizing and realizing” something – and “I think we all realized too many pharmaceutical manufacturers are offshore and that we need to repatriate them.”

Carter is right – but few echoed Carter’s comments.

Other members in Congress have bills to move more production to the U.S., but those members typically are not on the committees of jurisdiction.

Take for instance the Washington group – Americans for Accessible Medicine (AAM). They used to be called GPhA – known as the Generic Pharmaceutical Association. The rebranding took place in 2017. The board is much different now than in its early years – reflecting the offshoring of the pharmaceutical industry. Today, the same organization known as AAM is dominated by foreign drug manufacturers – mostly from India – a country plagued by warning letters and quality control.

David Gaugh, senior vice president for AAM, testified but only voiced his concern for the fast approval of the Generic Drug User Fee Agreement, which expires in September. Making life easier for domestic generic drug manufacturers is not top of mind as it is not in the majority of his members’ best interest.

It will take stronger leadership from Subcommittee Chairwoman Eshoo (D-CA) and Committee Chairman Pallone (D-NJ) to pass meaningful legislation in the House to support the reshoring of the generic drug industry, an industry that these FDA fees are supposed to support.

Generic Drug Shortages and How a Race to the Bottom in Price has Upended 30 years of Hatch-Waxman







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