FDA proposal could increase generics, but critics say they’ve seen it before

Critics say it undercuts bipartisan Senate bill

A new Food and Drug Administration (FDA) proposed rule is designed to speed up the availability of generic drugs and reduce costs for consumers. But its critics say it’s a pale imitation of the Senate bill passed in July limiting brand-name drug companies to only one 30-month extension of patents and provides legal standing to generic drug manufacturers that challenge patent listings in the Orange Book. (For a detailed discussion of the bill, S. 812, see the September issue of Drug Utilization Review.)

In a White House Rose Garden address, President Bush said the newly proposed rule was a result of findings in a recent Federal Trade Commission report, "Generic Drug Entry Prior to Patent Expiration." That study is an examination of whether brand-name drug companies could use the 180-day exclusivity and 30-month stay provisions of the 1984 Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act to delay or deter consumer access to generics.

The report found eight instances from 1992 through 2000 in which the brand-name companies listed patents after an abbreviated new drug application (ANDA) had been filed. The additional delay, beyond the first 30-month stay, ranged from four to 40 months. In the four cases that made it to court, the patent was found either invalid or not infringed by the ANDA.

The FDA proposed rule would permit only one automatic 30-month stay per generic drug application. It also would clarify requirements for listing drug patents in the Orange Book, limiting the types of patents that have the potential to block generic drug approvals.

In particular, the regulation would not allow drug manufacturers to submit to the FDA patents on such product aspects as packaging, metabolites, and intermediates that are unlikely to represent significant innovations. Manufacturers of new drugs also would have to provide additional information when they file their patents, discouraging them from submitting patents that are not permitted to be listed under the statute and regulations.

Health and Human Services Secretary Tommy G. Thompson estimates the proposed regulation could save consumers more than $3 billion annually. The proposal was published in the Oct. 24th Federal Register. The FDA will accept public comments on it for 60 days and then will work to issue it as a final rule.

A shadow of Senate bill?

Democrats spoke out quickly against the proposal.

"It closes one door to the pharmaceutical industry in their attempt to delay generics, but it opens up several others," Sen. Charles Schumer (D-NY) told the Associated Press. Schumer is an author of the Senate bill. "I think that within three weeks the pharmaceutical industry will find a way around it. That’s the tragedy."

A national organization for health care consumers is upset that the FDA proposal does not permit generic drug companies to legally challenge "frivolous" new patents filed by brand-name companies.

"While the administration’s decision to hasten the availability of therapeutically effective, much cheaper generic drugs is welcomed, it appears to be considerably weaker than legislation adopted by an overwhelming and bipartisan 78-21 margin in the U.S. Senate," says Ron Pollack, executive director of Families USA in Washington, DC. "The proposed regulations seem intended to undermine this strong legislative measure that now enjoys very significant, bipartisan, and growing support on Capitol Hill."

In light of skyrocketing drug costs and the pharmaceutical industry’s efforts to prevent generic drugs from coming to market, he continues, "much bolder action is needed" than the administration’s proposal.

The Pharmaceutical Research and Manufacturers of America in Washington, DC, which represents U.S. brand-name pharmaceutical manufacturers, has yet to speak about the proposal, saying it needs more time to review the details.

One pharmacy group, however, calls the FDA proposal a "good step in the right direction."

"It should increase access to lower-cost generic drugs," says Susan K. Bishop, manager of regulatory affairs and political action for the American Pharmaceutical Association (APhA) in Washington, DC.

APhA was not previously aware that the Bush administration would be releasing the proposed rule. However, the association was not surprised, she says. "The administration has been clear that it wants to do something for seniors and prescription drug costs. When you consider that and the recent action by the Senate, it is not surprising that the administration took some action.

"Making prescription drugs more affordable for consumers, and especially seniors, is a high public-health priority and I’m sure a major factor in the decision [to issue the proposal]," she adds.

Sen. John McCain (R-AZ), another author of the Senate bill, also applauded the administration’s recognition of the problem, but he encouraged the administration to push for legislation. "What is truly needed is legislation that will codify into law provisions that will guarantee that these drugs are affordable for those who need them. I hope that the administration is genuinely serious about this issue, and will urge the House leadership when it reconvenes in January to pass the generic drug legislation that has already been overwhelming adopted in the Senate."