PHARMACY

GPhA testifies before House subcommittee on generic user fees

BY Alaric DeArment

WASHINGTON — The generic drug industry’s main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

Testifying before the House Energy and Commerce Subcommittee on Health Thursday, Generic Pharmaceutical Association VP regulatory sciences David Gaugh said the generic drug user fee programs would "help to ensure that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than $1 trillion in savings to the nation’s healthcare system."

"The generic industry has stepped up to the plate to do our part to help ensure U.S. drug safety, establish a more level playing field among all participants in the U.S. pharmaceutical supply chain and significantly reduce the time needed to commercialize a generic drug," Gaugh said.

Heather Bresch, CEO of Pittsburgh-based generic drug maker Mylan, also testified before the subcommittee in favor of generic drug user fees. "Every consumer should have the peace of mind in knowing that every prescription, brand or generic, dispensed in the United States, is held to the same standard of quality regardless of whether the product or its ingredients originated in the [United States] or outside its borders. With a mission to protect and promote the public health, the [FDA] has a critical responsibility, along with industry, to ensure the safety, efficacy and security of the U.S. drug supply," Bresch said in her testimony.

"Unfortunately, [the] FDA is still operating as a domestic agency, under a 1938 law that has remained largely unchanged despite globalization of the industry, which has left it without the resources or legal authority to regulate the global drug supply that now serves the U.S. market. Just as the pharmaceutical industry has become global in order to meet its mission, so too must [the] FDA," Bresch added.

Generic drug user fees have long been a goal for the generics industry and are seen as a way to help reduce the FDA’s large backlog of generic drug applications.

 


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PHARMACY

FDA releases draft guidance for biosimilars

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

The Patient Protection and Affordable Care Act of 2010 contained a provision for an abbreviated regulatory approval pathway for biosimilars, but the task of creating regulations for them was left to the FDA itself. The guidance documents released Thursday include scientific considerations for helping companies demonstrate that a proposed biosimilar is similar to the original branded version, quality considerations for demonstrating biosimilarity and a document with common questions and answers.

"When it comes to getting new biosimilar products on the market, [the] FDA has taken an innovative approach to supporting their development at every step of the pores," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "These draft documents are designed to help [the] industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."

The generic drug industry, which has long pushed for a biosimilar pathway, praised the release of the draft guidance. "GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients," a statement released by the Generic Pharmaceutical Association read.

 


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FDA approves Mylan antimicrobial drug

BY Alaric DeArment

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan’s doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott’s Doryx.

Warner Chilcott launched a patent infringement suit against Mylan in the U.S. District Court for the District of New Jersey in response to the latter’s filing for FDA approval of the drug. The court is expected to reach a decision in March, and Mylan said it agreed not to launch the drug until then, though it expected to be the first to launch a generic version.

Doryx had sales of about $264.1 million in 2011, according to IMS Health.

 


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