WASHINGTON – The PDUFA package that's been cruising through Congress on its way toward reauthorization hit its first speed bump this week when a House subcommittee delayed marking up its version of the user fee bill.

In postponing Thursday's markup session to May 8, the leadership of the Energy and Commerce Subcommittee on Health said it wanted to reach a comprehensive agreement on the bill before the markup. "This legislation is too important to get wrong," Chairman Joe Pitts (R-Pa.) and Ranking Member Frank Pallone (D-N.J.) said.

One of the more controversial pieces of the subcommittee's draft bill is an expansion of the FDA's mission statement, which would force the agency to consider the economic impact of its decisions. At the subcommittee's final hearing on the bill last week, Janet Woodcock, director of the FDA's drug center, testified that the agency doesn't have the economic expertise that mission expansion would require. "I see this could have negative consequences," she said. (See BioWorld Today, April 19, 2012.)

The wording of a provision to encourage development of new antibiotics gave rise to more disagreement at the hearing. As written, the provision would grant five years of market exclusivity to any new antibiotic. Rep. Henry Waxman (D-Calif.) wanted it narrowed to cover only those drugs that fight life-threatening infections. He also proposed offering a shortened development path for the drugs rather than exclusivity.

Acknowledging that the subcommittee had not yet been able to come to full agreement on the draft bill, Waxman said he expected a consensus soon.

Meanwhile, a bipartisan version of the fee package raced through markup Wednesday in the Senate Health, Education, Labor and Pensions (HELP) Committee. In addition to setting drug and device user fees for the next five years, the Senate package creates new fees for generic drugs and biosimilars; makes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act permanent; requires early notification of events that could lead to drug shortages; upgrades the FDA's tools to police the global drug supply chain; and encourages broader use of accelerated approval. (See BioWorld Today, April 6, 2012.)

In addition, the Senate bill, known as the FDA Safety and Innovation Act, requires a number of studies that signal new directions Congress may take when PDUFA comes up for reauthorization in 2017. For instance, the bill sets up a working group to explore various options for making drug labeling accessible to blind and visually impaired patients. And it calls for the National Academies to study the possibility of offering financial "prizes" rather than exclusivity as a reward for medical innovation.

Some of the debate in Wednesday's markup session also pointed to possible future directions. Noting that the billion-dollar fines big pharma is paying to settle Department of Justice investigations isn't curbing illegal practices, Sen. Bernie Sanders (I-Vt.) proposed an amendment to revoke a drugmaker's data exclusivity when it violates federal drug laws.

Some committee members worried that such a penalty was too broad and that it would discourage settlements, dis-incentivize investment and practically eliminate patent protection. "You can't just ignore" such problems, HELP Committee Chairman Tom Harkin (D-Iowa) said, but he proposed that the appropriate penalty might be to force a drugmaker to settle for lower prices.

Another amendment that didn't get much traction was one that would have allowed consumers to buy cheaper drugs from online and bricks-and-mortar pharmacies located in Canada.

An amendment forcing the FDA to consider clinical trial data generated outside the U.S. also didn't go very far. Sen. Richard Burr (R-N.C.) argued that the end result might be that the U.S. would "price ourselves – from an R&D standpoint – right out of the market" because sponsors would have more incentive to conduct trials in other nations.

The bill does include a provision to optimize global clinical trials. It requires the FDA to work with other regulators and international organizations to develop uniform, scientifically driven clinical trial standards that would facilitate simultaneous global drug development. The measure also encourages use of foreign trial data to minimize the need to conduct duplicative trials and preclinical studies.

In addition, the Senate bill sets strict time frames for the FDA to review and draft a number of guidances. On that list is a guidance, to be completed within two years, on using social media to promote drugs.

Bioeconomy Blueprint Focuses on Jobs

While a House subcommittee debates the role economics and job creation should play in the FDA's mission statement, President Barack Obama released a national Bioeconomy Blueprint Thursday that's intended to guide federal agencies in enhancing economic growth and job creation while improving the health of Americans.

The blueprint, promised last October, identifies five strategic objectives to fuel a vibrant U.S. bioeconomy:

• support R&D investments that will provide the foundation for the U.S. bioeconomy, using novel funding approaches such as prizes and challenges;

• facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences;

• develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs while protecting human and environmental health

• update training programs and align academic institution incentives with student training for national work force needs

• identify and support opportunities for the development of public-private partnerships and precompetitive collaborations.

The Department of Health and Human Services committed to several initiatives in support of the blueprint, including taking better advantage of large pharmaceutical datasets to speed drug development, applying the latest genomics discoveries to quickly identify emerging microbial threats and accelerating research on nonembryonic stem cells as possible treatments for blood-related and neurological diseases.

FTC Loses Pay-for-Delay Bout

The FTC's fight against pay-for-delay settlements between brand drugmakers and generics was dealt another blow this week in a case involving Solvay Pharmaceuticals Inc.'s AndroGel.

In an opinion written by Judge Edward Carnes, the U.S. Court of Appeals for the 11th Circuit said pay-for-delay settlements do not violate antitrust laws as long as they don't expand the protection offered by the patent and the patent was not fraudulently obtained.

The FTC had appealed to the 11th Circuit, claiming that Solvay entered a settlement with three generic companies because it was not likely to prevail in a challenge to its patent for AndroGel (testosterone gel), which expires in August 2020.

Under the settlement, Watson Pharmaceuticals Inc., Par Pharmaceutical Companies Inc. and Paddock Laboratories Inc. could begin marketing generic versions of AndroGel Aug. 31, 2015.

The flaw in the FTC's argument, the court said, is that it "equates a likely result (failure of an infringement claim) with an actual result, but it is simply not true that an infringement claim that is 'likely' to fail actually will fail."

The court also chided the FTC for challenging the settlement based on what might have happened. "Predicting the future is precarious at best; retroactively predicting from a past perspective a future that never occurred is even more perilous," the court said. "And it is too perilous an enterprise to serve as a basis for antitrust liability and treble damages."

– Mark McCarty, Washington editor for BioWorld Today's sister publication, Medical Device Daily, contributed to this report.