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McCain, Schumer introduce generic drug bill

WASHINGTON (CNN) -- In an attempt to address concerns about the cost prescription drugs, Sen. John McCain, R-Arizona, and Sen. Charles Schumer, D-New York, introduced legislation Tuesday intended to make it more difficult for makers of brand-name drugs to keep cheaper generic drugs off the market.

The bill's sponsors say brand name companies that patent drugs are able to use loopholes in the current law to delay approval of less expensive generic drugs through litigation and by paying off generic companies.

"Our bill is about creating a stronger and more competitive marketplace by streamlining the current process for generic drugs to become available to the public," said McCain.

McCain and Schumer's legislation, backed by coalition of consumer groups, tries to close what the sponsors say are loopholes in the so-called "Hatch-Waxman" law of 1984 that helped pave the way for the generic drug industry.

Schumer told reporters his bill can "reduce the prescription drug costs by over 60 percent per prescription" and save consumers $71 billion in savings over 10 years.

For example, the prescription allergy drug Claritin costs on average $63.65 per prescription, while sponsors of the bill estimate its generic equivalent would cost $25.46.

"The large drug companies are playing by their own rules, unfortunately and unfairly forcing Americans to pay sky high prices for medication they can't live without," said Schumer.

Current law now gives the first generic drug applicant a 180-day market exclusivity. But brand name companies can pay that "first-to-file" generic drug maker to stay off the market, effectively staving off competition.

This legislation would expedite the second generic drug applicant's approval process if the first is delayed or found to be engaging in anti-competitive activities.

Also, brand name drug companies are now able to delay competition for 30 months by suing generic applicants. McCain and Schumer's legislation would eliminate the automatic 30 month delay.

The bill's sponsor's say brand name companies can also delay a generic drug's entry into the marketplace by abusing the FDA citizen petition process, used to monitor public concerns about drug approval. The legislation would instruct the Federal Trade Commission to investigate citizen petitions they suspect are being used to quell competition.

McCain, who chairs the Senate Commerce Committee, will hold a hearing on the legislation May 17.

The former GOP presidential candidate said if Republican leaders refuse to bring it up for full Senate debate, he will try to amend it to other bills under consideration.

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4:30pm ET, 4/16

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