FDA to speed up review of certain generic drugs

|

Generic drugs are getting more and more approvals?

Companies will be given priority if their application is the first one proposing a generic version of a brand name drug that is no longer protected by a patent or market exclusivity
User fees simply won't speed up generic drug approval times if brand companies are still able to use loopholes such as citizen petitions to block consumer access to affordable generics

While I wish that Generic drugs providers will get more and more exposure and market, I think that patented pharma corporations won't give up easily.

WASHINGTON (Reuters) - The U.S. Food and Drug Administration will accelerate its reviews of certain generic drugs, a top agency official said on Wednesday, a move the industry said could help get some cheaper alternatives on the market sooner.

Companies will be given priority if their application is the first one proposing a generic version of a brand name drug that is no longer protected by a patent or market exclusivity, said Dr. Steven Galson, director for the FDA's Center for Drug Evaluation and Research.

Applications filed before a patent or exclusivity ends would not be eligible under the new procedures now in effect.

Generic medicines that would address a public health emergency or nationwide shortage would also see faster reviews, he told a conference sponsored by the Generic Pharmaceutical Association.

"We recognize that there are certain situations under which it is advantageous to public health to expedite certain applications," Galson said.

The FDA has a backlog of more than 800 generic drugs awaiting an approval decision under the current process that evaluates all applications in the order it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.

Last year, the FDA received 766 generic applications, the agency said. About 40 applications a year are for those that, if approved, would be the first generic alternative to a branded drug.

At issue is a lack of staff and funding, the FDA and others have said. Reviews for brand name drugs are funded in part by company fees, but the FDA's work on generic bids is funded solely by the government.

"The resource constraints combined with an increased workload in the generics program is a double whammy," Galson told Reuters. "Particularly in this era of tremendous importance of saving health care dollars we just can't fall behind."

Generic Pharmaceutical Association President and Chief Executive Officer Kathleen Jaeger welcomed the priority reviews as a way to help patients and save the U.S. health care system millions of dollars.

"This action will mean that consumers will have more timely access to safe, effective and affordable generic medicines," said Jaeger, whose group represents $22.3 billion in annual U.S. sales.

FDA officials have suggested that generic drugmakers also pay fees to have their applications reviewed and the issue is likely to stir debate as Congress prepares to address agency funding next year before the fee program expires.

An internal FDA working group is also underway to see if it would be feasible to establish similar fees for generic companies, Galson told Reuters.

Critics say such funds, also paid by device makers, compel the agency to act in the interests of companies rather than patients and can lead to hasty approvals.

The generics industry, which welcomed the new priority program, has so far urged greater funding from Congress.

At the conference, GPA's Jaeger also said a number of other issues were keeping low-cost alternatives from the market, including citizen petitions filed with the FDA by brand-name companies seeking to block a generic approval.

"User fees simply won't speed up generic drug approval times if brand companies are still able to use loopholes such as citizen petitions to block consumer access to affordable generics," she said.

Top generic drugmakers include Teva Pharmaceutical Industries Ltd, Barr Pharmaceuticals Inc., Mylan Laboratories Inc., Watson Pharmaceuticals Inc. and Novartis AG's Sandoz unit.

The Pharmaceutical Research and Manufacturers of America, which represents branded drugmakers, has defended petition use. It had no immediate comment on the FDA's new priority system for generic competitors.

source