Bush Moves on Generic Drug Access

By: Associated Press
By: Associated Press

President Bush on Monday proposed an election-year solution to rising prescription drug costs, ordering the government to block pharmaceutical companies from filing multiple patent-protection lawsuits that can stall cheaper products for years.

``This is another important advancement in the cause of bringing more affordable prescription medicines to our seniors,'' Bush said in a morning appearance in the White House Rose Garden.

Senior citizens historically vote in high percentages during midterm elections and are being courted by both parties for the Nov. 5 elections that will determine control of Congress.

The Democratic-run Senate approved legislation three months ago designed to make generic drugs more available, but the Bush administration opposed it. Parts of the Senate-passed measure resemble Bush's proposal.

``I'm taking action to close the loopholes, to promote fair competition and to reduce the cost of prescription drugs in America,'' Bush said. He mentioned his support of senior citizens at least three times.

``This sounds like an Election Day conversion,'' said Sen. Charles Schumer, D-N.Y., who sponsored the Senate bill.

``This could be a very good proposal, but given the White House's track record on this issue, it could be just another loophole to let the name-brand drug companies delay the implementation of generic drugs,'' Schumer said.

Patent protections allow drug companies to recoup the cost of developing life-saving medicine. The patents eventually expire, allowing the drugs to be produced cheaper under generic brands.

Bush said ``the careful balance of the law is being undermined'' by drug companies the repeatedly seek 30-month delays in the expiration of their patents.

Bush intends to limit those so-called stays.

``Last year, the average brand name drug cost more than $72 per prescription,'' he said. ``The average price for generic drugs, which were just as safe and effective as the brand name drugs, were just $17 per prescription.''

``New drugs allow children with rheumatoid arthritis to walk and to go to school, new drugs shrink cancerous tumors and they control the advance of HIV, slow the progression of multiple sclerosis,'' Bush said.

The administration estimated the change would save $3 billion in drug costs per year.

Brand-name drug manufacturers sometimes file lawsuits against generic drug makers poised to put less expensive products on the shelves. The lawsuits invoke the 1984 Hatch-Waxman Act, which was meant to promote competition in the drug industry but which also gives the brand-name makers up to 30 months of additional patent protection while litigation proceeds.

The Federal Trade Commission found earlier this year that big pharmaceuticals are increasingly using this tactic to fend off competition and keep generics out of consumers' hands, sometimes for years.

Usually there is no such patent challenge, but in some instances the brand-name makers use the 30-month shield more than once.

Bush said his administration will move to limit the brand-name manufacturers to a single 30-month delay per drug. The White House also was moving to tighten requirements and increase disclosure rules for drug patent listings.

Bush said the policy change would encourage the creation of new drugs.

Democrats who learned of the proposal expressed skepticism that it would put generic drugs on the shelves faster.

The administration will publish its intentions in the Federal Register, open the plan up to public comment for 60 days and move to make the rule final after that, said a senior official, speaking on condition of anonymity.

The Generic Pharmaceutical Association said it had not seen the specifics of Bush's plan but had urged the administration to move in this direction. ``The administration understands the need to address the system abuses that have delayed affordable pharmaceuticals to consumers,'' said Kathleen D. Jaeger, the association's president.

Jackie Cottrell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, said the brand-name trade group would defer comment until after the official announcement.

The Senate passed legislation in July to limit brand-name pharmaceutical companies' usage of patent laws to thwart generic competition. The White House opposed a provision in the bill that would give a generic drug company a new right to sue if it believed that a drug company was filing a new patent solely to prevent competition.


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