PHARMACY

House passes FDA Revitalization Act, boosting agency’s enforcement powers

BY Jim Frederick

WASHINGTON The House of Representatives voted overwhelmingly Wednesday to significantly boost the Food and Drug Administration’s drug-safety enforcement powers and reauthorize the agency’s ability to collect user fees from drug manufacturers.

In a 405-7 vote, House members passed a revised version of the FDA Revitalization Act and sent it on to the Senate, which is expected to approve the measure as early as this week. The White House has signaled its approval of the bill, which would give new teeth to the FDA’s drug-safety oversight procedures and reauthorize the Prescription Drug User Fee Act.

Missing from the bill, as expected, is any provision for creating a clear approval pathway at the FDA for generic versions of bio-engineered drugs. But some lawmakers, including Democratic Rep. Henry Waxman of California and Rep. Frank Pallone, D-N.J., have pledged to pursue biogeneric legislation separately in the coming months.

The bill passed by the House renews the PDUFA program for five years; if passed by the Senate and signed into law by Pres. Bush, as expected, it will avert a shutdown of that program prior to the scheduled Sept. 30 expiration of PDUFA’s current mandate. The program, which must be renewed by Congress every five years, will pour a total of more than $440 million in user fees into the FDA’s operating budget from drug and medical device makers to help defray the costs of reviewing hundreds of new-drug applications.

More significantly, the legislation greatly expands the agency’s responsibility for long-term, post-approval drug outcomes and patient safety. To do so, it arms the FDA with new authority and additional funding to regulate advertising and drug labeling, and to establish a surveillance system to analyze data and track long-term drug use and safety among millions of patients.

According to a new survey from American University’s Center for Congressional and Presidential Studies, expanding the agency’s drug-oversight capabilities has strong support from the public. More than three-quarters of those surveyed say prescription drug safety is at least somewhat important to them in deciding their vote for the 2008 presidential election, according to the center, and nearly half of Americans, 47 percent, rate the FDA’s overall performance as only “fair” or “poor.”

“At a time when Congress is debating the FDA Revitalization Act to strengthen the safety of prescription medicines and overhaul the FDA, this survey validates that drug safety is a real concern for the American public,” said James Thurber, director of the study center. “The survey shows…there is a clear desire and expectation among participants for regulators to balance speed of approvals with their responsibility of reducing safety risks.”

Fully 64 percent of those polled by American University also declared the U.S. health care system “broken.”

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CVS to offer flu vaccinations in more than 4,000 stores

BY Allison Cerra

WOONSOCKET, R.I. CVS/pharmacy plans to help Americans stay healthy by offering flu vaccinations in over 4,000 of its stores, the company said Wednesday.

The flu vaccinations, which will be offered to customers by Oct. 1, will vary in cost based on location. Vaccines for Medicare Part B beneficiaries who present their Medicare Card will be available at no charge, provided they have not assigned their Medicare benefits to a private Health Maintenance Organization. The offer to receive the flu shots will run through November.

“The annual flu shot clinics at CVS/pharmacy are part of our commitment to help communities stay healthy,” said Papatya Tankut, R.Ph., Vice President of Pharmacy Professional Services at CVS/pharmacy. “By offering convenient locations for flu vaccinations, we’re providing additional opportunities for people across the country to get vaccinated before the peak flu season begins.”

Last year, nearly 400,000 people received flu shots at CVS/pharmacy.

It is strongly recommended people ages 50 and older, and/or have chronic illnesses like diabetes and asthma, receive a yearly flu vaccination, according to the Centers for Disease Control.

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Adams, Lipocine to develop new cough medicines

BY Drew Buono

CHESTER, N.J. Lipocine and Adams Respiratory Therapeutics have entered in an agreement to develop new prescription adult cough products.

Under the terms of the agreement, Adams receives exclusive rights from Lipocine to develop and market multiple prescription adult cough products. Adams will be responsible for performing clinical development, regulatory submission, manufacture, and commercial operations. Lipocine will be responsible for completing the product development work.

Lipocine will have the opportunity to receive reimbursements and payments in exchange for completing development milestones. “Given the large and growing size of the respiratory market, and how patients can benefit from enhanced dosage forms and regimens, we are very pleased to partner with Adams, a company highly respected for its commercialization accomplishments,” said Dr. Mahesh Patel, president and chief executive officer of Lipocine.

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