U.S. Details New Rules to Make Generic Drugs More Readily Available

The Bush administration announced regulations Thursday to limit the ability of the major drug makers to block competition from low-cost generic drugs.

The regulations will allow the major companies only one 30-month delay of a generic drug’s entry into the market for resolution of a patent dispute; the big firms will no longer be able to obtain patent extensions based on “frivolous” innovations, such as new packaging; and to get generic drugs to market quicker, the Food and Drug Administration will accelerate its procedures for approving generics.

President Bush, speaking here to an audience of medical personnel and seniors, said the combination of the new generic drug regulations and the Medicare overhaul legislation moving through Congress should help seniors and others on fixed incomes cope with the rising cost of drugs.

“We live in an age of miracle drugs,” Bush said. “Millions of our citizens have found healing and hope from medicines that were discovered and created in this country. But the challenge for America is to make sure that lifesaving drugs are both affordable and available to America’s seniors.”

Another of the new rules will allow criminal charges to be brought when drug companies are suspected of making false claims during the patent process.

“By taking these actions, we will bring generic drugs to the market much more quickly -- in some cases, years earlier,” Bush said. “And this should save the American consumers about $3.5 billion each year.”

The FDA said the cost of filling a typical prescription for a brand-name drug is about $72. For those drugs with generic equivalents, the cost of a comparable prescription is only $17, the FDA said.

FDA Commissioner Mark B. McClellan said making cheaper generic drugs available more quickly was “one of our major priorities.”

Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, did not directly criticize the new rules. But he said the current system “works well,” and he described the new rules as “lengthy and complex.”

Drug patents expire 20 years after inventors file them, which they must do when they make the composition of their new compounds public at the time of petitioning the FDA for approval to market them.

Several of the early years of the patent are eaten up by the approval process. Drug makers may have as few as 12 years of patent protection left when the drug reaches the market -- not enough time, the big companies argue, to compensate for the huge costs of development.

When a generic drug maker petitions the FDA for approval of an equivalent to a brand-name drug whose patent is expiring, the inventor of the original drug can sue to challenge the generic company for patent infringement.

In this circumstance, the current system requires the FDA to freeze the approval of the generic for 30 months.

Under the regulations issued Thursday, the company that invented the brand-name drug will be limited to one 30-month freeze.