Washington Editor

WASHINGTON - When a piece of legislation crafted by Sens. John McCain and Chuck Schumer passed the Senate earlier this summer, representatives of the generics drug lobby must have been patting themselves on the back.

That's because the legislation (S.812) would close some pretty wide loopholes that have enabled the pharmaceutical industry to extend patents and retain rights to drugs under the Hatch-Waxman Act of 1984. In particular, McCain-Schumer would limit pharmaceutical companies to one 30-month stay or postponement when a generics developer seeks to challenge a patent. Current law allows unlimited extensions, giving companies the ability to stall generics for years.

Rep. John Thune (R-S.D.) has introduced similar legislation in the House.

Biologics are not included under Hatch-Waxman, but according to the Washington-based Generic Pharmaceutical Association (GPhA), their time is coming.

Steve Bende, vice president of science, professional and regulatory affairs at GPhA, told BioWorld Today that biologics were not aggressively pursued as part of this summer's Hatch-Waxman reform because "it would have been too much to bite off and chew."

Nevertheless, biologics are in GPhA's radar scope. "Depending on whose analysis you read, in the next few years, $5 billion of the biologics market will become available when patents start expiring," Bende said.

They [FDA] have the authority to develop and implement an abbreviated pathway for generic biologics, but chances are, it is probably going to take Congress to take action to tell them to do it," he said. "But in the truest legal sense, I think most people would agree that the agency can do this on its own. Given all the political and other ramifications, they are probably going to wait for Congress."

Indeed, the Washington-based Biotechnology Industry Organization (BIO) strongly believes that Congress needs to be involved in any decision that would allow generic companies to produce biologics. "This is a matter that is too significant scientifically to be resolved solely by a bureaucrat's discretion," Steve Lawton, BIO's vice president for regulatory affairs and general counsel, told BioWorld Today. "It must be resolved by Congress and we believe we have the high ground in terms of the science."

Existing law requires generics to be tested under an abbreviated pathway designed to prove that a product is safe, effective and the bioequivalent of the brand-name drug.

But Bende is not presuming that producing a generic biologic would be such an easy or cheap task.

"I think one of the things that's confusing is, you'll hear BIO and Biogen come out and say the science isn't there for generic biologics," Bende said. "Well, I don't think they are meaning the same thing other people mean by generic biologics."

Biogen Inc., of Cambridge, Mass., owns Avonex, one of the approved biologics that could eventually be targeted by the generics industry. Its patents on the drug expire in 2011 and 2013, although erroneous information had been published recently saying they would expire next year. It's the drug's seven-year orphan exclusivity for multiple sclerosis that expires next year. Amgen Inc., with its blockbuster biologics, is among other companies watching the issue.

Jim Green, vice president of clinical and preclinical development sciences at Biogen Inc., told BioWorld Today, "To say BIO and Biogen are the ones representing this position, I think we are, but we're not alone. There is within the biotechnology community a recognition that clearly the complexity of products produced by recombinant DNA technology are orders of magnitude more complicated than small molecules and what we have said all along is that the path forward to obtaining what people refer to as a generic biologic would have to be very different than what is the current and only path that is used for a generic drug and that's the one that is followed by small molecules."

Bende said the Hatch-Waxman definition of generic means "you can't ask for more clinical studies other than bioequivalence."

"What we mean is an abbreviated approval pathway, meaning the science of an individual molecule would dictate what kind of clinical testing is needed," he said. "So the human growth hormone would probably be something that would need a lot less clinical testing than you would need for something that is a much more complex molecule."

To that, Lawton responded, "The generics are flat wrong on the science and they are putting economic considerations over patient welfare.

"Under today's science, there is no shortcut for clinical trials demonstrating both safety and effectiveness," he said. "Perhaps the trials don't need to be as large as the pioneers, but every follow-on biotech product in the U.S. and in other countries with regulatory systems equivalent to ours have required clinical trials for safety and effectiveness. It is a matter of science; the science could be different five or seven years from now, but the science is not there yet because the manufacturing process is so difficult."