User Fees

The lead sponsor of antibiotic incentive legislation Tuesday (April 24) is raising concerns to FDA about a separate proposal floating on Capitol Hill for a limited population antibiotic drug approval measure, saying the limited approval idea could damage the incentives in his broader bill and discourage antibiotic development, although committing to further vetting the idea, according to a letter obtained by FDA Week. In the letter Rep.

Following technical input from FDA, including the addition of language that could effectively curb broader and off-label uses, the Infectious Diseases Society of America is touting support for its limited population antibiotic drug (LPAD) pathway from the agency and Energy and Commerce's top Democrat, although Rep. Henry Waxman (D-CA) is still seeking assurances that off-label prescribing would be limited and FDA has yet to officially endorse the idea.

It could be difficult to translate a narrowly written device predicate nullification proposal into legislative language with undefined legal terms like "design flaws" that could create subjective legal areas for FDA, an industry source said, adding that this could pose hurdles for those seeking the proposal's inclusion in user fee legislation. Safety advocates counter that the bill should not be so narrowly written to prevent FDA from having authority to take action, as they continued lobby efforts with letters to congressional committees citing the predicate issue as a top priority.

Sen. Orrin Hatch (R-UT) is working with Finance Committee members on drug shortage legislation that would change federal reimbursement for some sterile injectable drugs that are susceptible to shortages and would grant five years of exclusivity to manufacturers that produce drugs to alleviate a shortage, according to a discussion draft of the bill and an internal email obtained by Inside Health Policy.

The chances of drug tracking measures being included in the broader FDA user fee/reform package appeared to wane this week in both chambers of Congress. A House Energy and Commerce lawmaker who backs drug tracking initiatives, including an industry-backed drug proposal, clashed with FDA's top drug official who said the industry plan would not prevent counterfeit and adulterated drugs from reaching patients and therefore would not solve the problem stakeholders are trying to address.

Infectious disease experts believe their best chance of getting a recently proposed limited population approval mechanism into FDA user fee legislation is to focus on the plan's benefits in spurring new antibiotics, even though the idea has been discussed for broader uses such as obesity drugs. The Infectious Diseases Society of America is touting support from a slew of drug companies and public health groups as it ramps up lobby efforts in support of the limited approval proposal.

Congressional committees working on the reauthorization of FDA user fees, including a fee for the health reform-created biosimilars review pathway, could begin marking up bills the last week in April, sources said, with the Senate health committee planning to convene a markup the week of April 23. A bipartisan draft is expected from the House Energy and Commerce Committee in the coming weeks, a source said, noting that both chambers still have to address gaps in their legislative measures.