Bush Administration Speeds Up Generic Drug Approval Process
The change takes effect Aug. 18 and limits brand-name companies to only one 30-month stay blocking a generic drug’s entry into the market. The move will prevent the current practice of patent-holders filing several lawsuits, with each one automatically triggering a 30-month stay.
President Bush told a crowd of doctors and seniors at a New Britain, Connecticut hospital Thursday that companies’ investments and innovations in developing new drugs should be protected “for a while.”
“Yet when a patent expires, other companies have the right to make a safe, lower-cost generic version of the drug,” he said. “The initial manufacturer of a drug will not be allowed to use the legal process for endless delay, which hurts our consumers in America.”
The president also said the move will save consumers $3.5 billion each year by making less expensive generic alternatives available more quickly.
Aside from limiting patent-related delays, the Food and Drug Administration is also aiming to shave three months off its consideration of a generic drug-making application, currently a 20-month process. The FDA said Thursday it will speed up this process by providing better advice to generic manufacturers on how to file a drug application that will be approved on the first try. Currently, these small companies often must resubmit the same application several times before getting approval.
“Helping patients get lower-cost generic medicines, once the appropriate patent protection has expired, is therefore one of our major priorities. Our new rule and our new procedures are important steps in making more generic drugs available more quickly,” FDA Commissioner Mark B. McClellan said.
The FDA had first proposed the new rule preventing brand-name companies from filing multiple lawsuits last fall, and finalized it Thursday — one day after a key Senate committee approved legislation that would go even further.
The Senate bill also would block multiple lawsuits, but it includes other steps to thwart delays in the sale of cheaper generic versions — including abuses in which the brand-name maker pays its generic competitor to stay out of the market.
Beyond attempting to lower drug costs by increasing access to generics, President Bush also urged legislators to further decrease the amount seniors are spending on medicine by passing a Medicare prescription drug bill.
The legislation, which is currently making its way through the Senate, would subsidize Medicare beneficiaries’ purchase of prescription drugs for the first time. Also, it would create a new managed care option under the government-run health care program, a change that the president has recommended to help modernize the program and improve its long-term finances.
Under the bill, seniors enrolling in preferred provider organizations, known as PPOs, would have a portion of their prescription drug costs paid as part of their overall coverage beginning in 2006. Seniors remaining in traditional Medicare could purchase stand-alone coverage.