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Faster market access for generics in US

Published on 29/10/03 at 04:19pm

Laws governing the entry of generic drugs on the US market are to be streamlined in an effort to cut prescription drug costs for patients and health insurance schemes.

President George Bush has put forward a compromise proposal after months of wrangling on Capitol Hill about how far the reforms should go in accelerating generic competition.

Loopholes that currently allow pharmaceutical companies to delay the launch of cheaper competition will be closed, saving an estimated $3.5 billion each year.

The new regulations will allow pharma companies to issue just one 30-month delay for each new generic drug application, if they decide to sue over its patent, scrapping their current right to issue multiple and consecutive challenges.

The new rules, due to come into force in August, are aimed at preventing frivolous patent extensions such as modifications to the colour of pills or a combination of ingredients not related to the drug effectiveness.

President Bush said: "Our healthcare system is the best in the world, and we need to keep it that way. But wee got problems wee got to deal with."

More radical changes have received the backing of the Senate Health Committee and may yet become law as part of wider reform of the Medicare insurance system.

The Committee backed giving generic companies the right to file counterclaims when sued, thus potentially avoiding any delay, as well as outlawing other tactics to block competition including paying generic companies to keep their products off the market.

Alan Holmer, President of the Pharmaceutical Research and Manufacturers of America, said the current Hatch-Waxman law worked adequately, with just 10% of healthcare spending going on branded medicines. He said PhRMA will now study the proposed changes, adding: "We need to be sure that the rule clarifies current law in a way that supports continued development of new and better medicines that patients need."

The Bush administration changes are part of a series of reforms to the way the FDA deals with generics drugs, after increasing public disquiet with America Medicare health insurance system and high prescription drug costs.

The Agency will receive an extra $13 million for its generic drug programme in next year budget, allowing it to hire 40 new generic drugs experts to speed up the review process.

FDA Commissioner Dr Mark McClellan said: "Americans deserve greater access to affordable, safe and effective medications. Helping patients get lower-cost generic medicines, once the appropriate patent protection has expired, is therefore one of our major priorities."

Within five years the reforms are expected to reduce the average generic drug approval time by three months, costing manufacturers of major products near patent expiry millions of dollars in lost revenue.

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