"This legislation would make cost-effective generic drugs more available by restoring the original intent of the Hatch-Waxman law and closing the loopholes that are delaying competition and slowing the entry of lower-cost generic drugs into the market," said Senator Collins.
Prescription drug spending in the United States has increased by 92 percent over the past five years to nearly $120 million. "These soaring costs are a particular burden for the millions of uninsured Americans, as well as those seniors on Medicare who lack prescription drug coverage. Many of these individuals simply are priced out of the market, or forced to choose between paying the bills or buying the pills that keep them healthy," the Senator said.
The Greater Access to Affordable Pharmaceuticals Act is supported by coalitions representing the nation's Governors, insurers, businesses, organized labor, senior groups, and individual consumers who are footing the bill for expensive prescription drugs. The cost of popular drugs such as Cardizem CD, Cipro, Prilosec, and Zantac could be cut in half if generic alternatives were available. The bill would limit brand name manufacturers to a single 30-month stay for patents listed at the time of the brand product approval. This will eliminate the brand-name manufacturers' ability to ‘stack' multiple and sequential automatic 30-month stays during patent litigation in order to keep generics off the market and extend their market exclusivity indefinitely.
For subsequent patents for which no automatic 30-month stay is available, a brand name company can still obtain a preliminary injunction based on merit to protect its patent rights.
The legislation also would prevent the current 180-day exclusivity provision of Hatch-Waxman from becoming a bottleneck for subsequent generic competitors. Under Hatch-Waxman, the first generic drug company to file an application with the FDA certifying that the patents on a brand name product are either invalid or will not be infringed is granted 180 days of market exclusivity once its application is approved. Entry to the market for other generics is therefore frozen until the 180-day period runs out on the first-to-file.
This provision has made it attractive for a brand name to pay the first-to-file generic company to stay off the market, which effectively staves off other competition for an extended period. Under this bill, the first generic applicant would forfeit its 180-day exclusivity period if it failed to go to market or entered into an agreement with a brand-name company that the FTC determines to be anti-competitive. If the first generic applicant forfeits its 180-day exclusivity, it would roll to the next generic company in line. If there is no second company in the pipeline with a product ready to go, any generic with an approved application could go to market immediately.
"This bill will make prescription drugs, which have become vital components to the good health of millions of Americans, more affordable for everyone."
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