Bush Plans New Rules On Generic Medicine
By Amy Goldstein
Washington Post Staff Writer
Monday, October 21, 2002; Page A01
URL: washingtonpost.com
President Bush plans today to propose new rules designed to make it easier for Americans to buy generic medicine by reining in the ability of brand-name pharmaceutical companies to keep lower-price drugs off the market.
Administration officials last night estimated that the plan, which could take effect within the next several months, could shave $3 billion a year off the nation's rapidly escalating expenditures on prescription drugs.
The officials, speaking on condition of anonymity, said Bush essentially will call for a new interpretation of a law that covers how the brand-name drug industry gets and preserves patents for the therapies it develops.
The White House is responding to criticism of the industry, including in a recent federal study, that has accused the companies of exploiting loopholes in the law to thwart competition -- and thus increase the price of medicine for patients, employers and government-run insurance programs.
"The president believes Americans, particularly seniors, cannot afford to wait any longer for lower prescription drug costs," an official said.
The availability of generic drugs traditionally has not been a prime political topic, but it has gained prominence this year for two reasons: Pharmaceutical prices have continued to soar by about 20 percent a year, and Congress and the White House have proven unable to reach agreement on a range of other popular health-care issues, including a way to help older Americans pay for medicine.
Bush's announcement, which the White House is according the formality of a Rose Garden ceremony, will come three months after the Senate approved legislation intended to foster the availability of generic drugs. The administration opposed that measure, even though parts of it resemble the proposal that Bush is to announce this morning.
As word -- but not the details -- of the White House plan began to filter out last night, the association representing generic drug manufacturers said the proposal sounded constructive, although perhaps not as far-reaching as the companies would like.
Sen. Charles E. Schumer (D-N.Y.), one of the main sponsors of the Senate bill, was skeptical. "This sounds like an Election Day conversion," Schumer said in an interview. "This devil will be in the details. This could be good, but given the White House's previous record, it could also be another loophole that will allow the drug companies to further delay approval of generics."
In a briefing, an administration official said the proposal will have at least three parts. One section would address a problem, highlighted in the study by the Federal Trade Commission released in July, in which brand-name companies sometimes exploit a rule that enables them to get a 30-month stay whenever a generic manufacturer challenges their patent. The problem, the report said, is that brand-name companies increasingly obtain repeated 30-month stays, effectively blocking competition for years.
Under the plan Bush will announce, a brand-name company would be allowed just one such stay, to give the Food and Drug Administration, which regulates medicine, time to determine whether the generic should be allowed onto the market.
Last night, Schumer and Kathleen D. Jaeger, president and chief executive of the Generic Pharmaceutical Association, said they believed the administration's plan might prove more lenient than the Senate bill for a technical reason: The administration official said it would allow a single stay each time a generic company challenged a patent. In contrast, the Senate version, which the generic manufacturers endorsed, would allow such stays only on patents that were filed at the time the brand-name drug originally was approved.
Another aspect of the administration's plan would make it more difficult for brand-name companies to ward off competition by filing frivolous new patents on their drugs. Under the proposal, such companies could not get new patents to cover different packaging of old medicine, different ingredients added to the medicine or different forms of the drug.
An official emphasized that the rules still would permit brand-name companies to get patents for new uses of drugs, saying that the administration did not want to deter research into beneficial therapies.
In addition, the proposal would require companies to list more detailed information when they file a patent and to certify that it is true.
Although Bush will outline the changes, their details will lie in a proposed FDA regulation, which an administration official said would be made public this week. The agency will invite reaction to the proposal for 60 days, and the administration would like to put the changes into place "soon thereafter," the official said.
Asked whether the White House expected the powerful lobby for brand-name drug manufacturers to go to court to try to stop the plan, the officials said they could not predict. "We think we are on quite solid legal ground," one said.
© 2002 The Washington Post Company |
