What: All Issues : Health Care : Access to Affordable Prescription Drugs : S 1082. (Food and Drug Administration overhaul) Allard of Colorado amendment on exclusive drug patent agreements for pharmaceutical companies/On agreeing to the amendment
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S 1082. (Food and Drug Administration overhaul) Allard of Colorado amendment on exclusive drug patent agreements for pharmaceutical companies/On agreeing to the amendment
senate Roll Call 148     May 02, 2007
Y = Conservative
N = Progressive
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This vote occurred on an amendment by Wayne Allard, R-Colo., that would delete language in a bill that limits how long a pharmaceutical company's drugs can be shielded from competition. Currently, drugmakers are allowed six months of exclusivity on certain drug patents if they find a new pediatric use for a drug. But the underlying bill would cut the time period to three months for drugs that make at least $1 billion in annual sales. The limitation is intended to prevent drug companies from taking a "blockbuster" drug (or one that makes significant profits), performing minimal pediatric research, and then obtaining an exclusive patent.

The amendment was offered to a bill that would overhaul the Food and Drug Administration (FDA)'s drug approval program. This program essentially allows pharmaceutical companies to pay the FDA for the costs or reviewing new drugs for approval, if they are found to be safe. The money is used to pay for the salaries of reviewers and the cost of the reviewing process.

Allard said the program the bill would limit has been extremely successful in providing an incentive to the pharmaceutical industry to put more effort into researching medicine for children. Allard said this has translated directly into more pharmaceuticals doctors can use for children's ailments.

"For the life of me, I don't understand why the bill's sponsors feel it is important to put this provision in the bill. In my view, we should not be removing or reducing the incentive for any pharmaceutical company to invest in children," Allard said.

Ted Kennedy, D-Mass., said that the bill seeks to limit the program because some pharmaceutical companies have misused it. Kennedy said some companies have reaped billions of dollars worth of sales for "blockbuster" drugs in the absence of competition while only expending a few million dollars on a study that satisfies the letter of the program.

"Clearly, one must provide incentives to develop new drugs for children, but we must be responsible in doing so," Kennedy said. "Those extra 6 months don't just apply to sales for use in children, they apply to all sales.. That means a heart drug tested in children would get 6 months protection from competition, so it can wrack up big returns. The amendment we face embodies a policy that has no proportionality. It gives the same broad protection to a drug such as Lipitor or Xanax as it does to a specialty drug that might be helpful in treating ear infections in children."

The amendment was defeated on a vote of 41-53, with those Democrats present voting unanimously against it. The majority of Republicans present voted for it, though five sided with Democrats. Thus, the bill went forward with language that would decrease the time period pharmaceutical companies can have exclusive drug patents if they also do research on pediatric uses for the drug.

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