Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

Bush Seeks Faster Generic Drug Approval (part 1)


August 5th, 2008 by admin


Start

President Bush today proposed a way to speed the approval of low-cost generic versions of prescription drugs, and consumer groups lauded the proposal as a worthy first step, although they said it was too late and did not go far enough.

At least as significant as the details of Mr. Bush’s announcement was the fact that he joined a chorus of critics who say makers of brand-name drugs have staved off generic competition by improperly manipulating drug and patent laws.

”Our message to brand-name manufacturers is clear,” Mr. Bush said in an appearance in the Rose Garden. ”You deserve the fair rewards of your research and development. You do not have the right to keep generic drugs off the market for frivolous reasons.”

Patients’ groups and some Democrats said Mr. Bush should have expressed his views three months ago, when the Senate was debating legislation on the issue.

Representative Richard A. Gephardt of Missouri, the House Democratic leader, described the president’s initiative as ”a cynical election year ploy” intended to appeal to elderly voters who are struggling with high drug prices.

Mr. Bush announced that the Food and Drug Administration, in a reversal of longstanding policy, would propose rules to limit the ability of brand-name drug companies to delay or block the sale of generic drugs, which typically cost much less. Agency officials said they did not need Congressional approval for the rules, which officials expect to take effect next year.

”By this action,” the president said, ”we will reduce the cost of prescription drugs in America by billions of dollars and ease a financial burden for many citizens, especially our seniors.”

In July, the Senate passed, 78 to 21, a bill to speed approval of generic drugs. The House has not taken it up.

Senator Charles E. Schumer, the New York Democrat who is chief sponsor of the Senate bill, said Mr. Bush’s proposal would close some loopholes but open others.

”The administration gives with one hand, and they take away with the other,” Mr. Schumer said. ”The timing is suspicious. This looks like an Election Day conversion.”

Even so, executives of generic drug manufacturers praised the proposal, saying it could prevent many of the abuses that brand-name pharmaceutical companies have committed. Jake Hansen, vice president of Barr Laboratories, a large generic based in Pomona, N.Y., said:

”These proposals, on their face, are very positive. They are not as far-reaching as the Senate bill. But the impact would be pretty powerful and can come a lot sooner than if we drag through another year of Congressional fights.”

The proposal ”would probably take care of 70 percent of the problems” that would the Senate bill would solve, Mr. Hansen said.

A lobby for the elderly, AARP, said the proposal could provide ‘’significant relief for millions of citizens.”

Senator Susan Collins, the Republican of Maine who supports the Senate bill, said: ”The administration’s proposal is a step in the right direction, but does not go far enough. legislative action is still needed.”

In 1984, Congress established a delicate balance, providing patent protection and research incentives for brand-name drug makers, while encouraging generic companies to sell low-cost copies of those medicines as soon as the patents expire.

”Unfortunately,” Mr. Bush said today, ”the careful balance of the law is being undermined” by the tactics of brand-name drug companies.

Several lawyers for drug companies predicted that the industry would challenge the final rules in court if they resembled the proposal issued today.

”The government expects to be sued,” said Marc J. Scheineson, an associate commissioner of the Food and Drug Administration from 1991 to 1993 who is now a lawyer. ”The stakes are enormous. With sales of $1 million a day per drug, the financial consequences are so great that the brand-name drug industry has nothing to lose by challenging the regulation.”

The proposed rules stipulate that when a brand-name manufacturer believes that a generic product has infringed its patents, it can delay approval of a generic copy for 30 months, while a court tries to resolve the dispute. In some cases, brand-name companies have blocked competition for much longer, by filing additional patent claims and piling 30-month stays on top of one another.

End

Posted in General Information |

Leave a Comment

Please note: Comment moderation is enabled and may delay your comment. There is no need to resubmit your comment.