House Bill Seeks to Cut $200 Million From White House’s FDA Funding Request

The House Appropriations Committee is proposing $2.6 billion in new funding for the FDA, roughly $200 million less than President Barack Obama requested, but no changes to the administration’s proposed user fee levels for drugs and biologics — which total about $1.2 billion.

Under the proposal, prescription drug user fees would increase from $798 million to $826 million, generics fees would climb from $312 million to $320 million, and biosimilars and biologicals fees would grow from $21 million to $21.5 million.

Last week, the committee released a report shedding light on how it wants those fees to be applied, ahead of a markup of the bill, which was subsequently postponed. Major issues include generic labeling, drug compounding and shortages. The bill was sent to the subcommittee that oversees the FDA, which approved it by voice vote on June 18.

The bill would require the FDA to issue a final rule on generic labeling that makes the agency the final decision maker on when a company has to change its labeling and establishes a process by which the FDA can collect and analyze safety information to determine if a labeling change is required, according to the committee’s report. The rule should include timelines for the agency to take action on new safety information and for drugmakers to implement labeling changes.

The committee also wants to the FDA to waive or exempt fees for small generics makers, a proposal that is in line with a request made by the Society of Chemical Manufacturers and Affiliates’ Bulk Pharmaceuticals Task Force during last week’s public meeting on reauthorization of the Generic Drug User Fee Act.

The bill also includes a provision prohibiting the FDA from using funds to require or permit distribution of a prescription drug or biologic without printed prescribing information.

The bill also would require the FDA to issue final guidance on mixing, diluting or repacking biological products outside the scope of an approved BLA, as the panel sees the need for close inspection and supervision of large-scale compounding and repackaging of sterile injectable drugs and biological products.

Drug Shortages

The proposal also would direct the FDA to report to Congress within 90 days on when it will complete its review of active pharmaceutical ingredients for use by compounding pharmacists.

The committee commends the FDA’s efforts to prevent drug shortages and urges the agency to continue working with industry to resolve future shortages. It also would require the FDA to issue a report on steps to maintain an adequate supply of tuberculosis drugs.

The bill would provide an increase of $4.2 million for medical product safety initiatives, including $2.5 million to combat antibiotic resistant bacteria. The committee calls on the FDA to support collaboration with industry on adaptive clinical trials and labeling changes to foster new antibiotic development. The provision is in line with a White House plan calling for drugmakers to partner with NIH, academics and biotechnology companies to develop new antibiotics.

The committee’s Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee held a hearing to review President Obama’s budget request in March.

The bill, which has not been assigned a number, is available at www.fdanews.com/06-24-15-appropriations-bill.pdf. The report explaining the bill is here: www.fdanews.com/06-24-15-budget.pdf. — Jonathon Shacat