PHARMACY

HHS announces $1.1 billion in HIV/AIDS grants

BY Adam Kraemer

WASHINGTON HHS Secretary Mike Leavitt this week announced grants to all 50 states, Washington, D.C., and U.S. protectorates of more than $1.1 billion to provide primary care, medications and services for low-income and underinsured people living with HIV/AIDS.

The majority of the grants, funded under Part B of the Ryan White HIV/AIDS Program, are used support state AIDS Drug Assistance Programs that provide prescription medications for HIV/AIDS patients.

“These Ryan White HIV/AIDS Part B grants help ensure Americans, especially those in rural and underserved communities, affected by HIV/AIDS get access to the care they need through quality health care and support systems,” Leavitt said. “These grants strengthen community, city and state capacities to care for those with HIV.”

Fourteen states, including New York, Ohio, Pennsylvania and both Carolinas, will also receive Emerging Community grants based on the number of AIDS cases over the most recent 5-year period.

Part B awards also include formula base grants that can be used for home and community-based services, insurance continuation, ADAP assistance and other direct services. “Ryan White Part B awards reflect the urgent need for life-saving medications for those living with HIV/AIDS,” said Elizabeth Duke of HHS’ Health Resources and Services Administration, which manages the program. “Today we are thankful and proud that all ADAP waiting lists have been eliminated.”

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Major drug companies fight stronger restrictions on off-label marketing on drugs

BY Diana Alickaj

WASHINGTON Ten major drug companies have formed a coalition and will submit their arguments to the Food and Drug Administration to push for looser proposed restrictions on off-label marketing, according to published reports.

The 10 companies include Pfizer Inc., Bayer Corp., the U.S. unit of Bayer AG; AstraZenecaPLC; and Johnson & Johnson who will be represented by Daniel Troy a former FDA Chief Counsel and is currently working with APCO Worldwide Inc.

Merck & Co., according to two reports from the Journal of the American Medical Association, was reported to have not effectively marketed the risks of its painkiller, Vioxx, which reportedly served as a risk for heart attack to Alzheimer’s patients. Congressional investigators also have accused Merck and Schering PloughCorp, the makers of Vytorin, a cholesterol drug, of trying to withhold information that questioned the drug’s effectiveness. These two instances are one of many in which Congress is trying to place stronger restrictions on the companies marketing strategies for these drugs.

According to published reports, a poll conducted during an annual conference sponsored by the drug-marketing magazine DTC Perspectives stated that 60 percent of participants felt that Congress might place limits on TV advertising for pharmaceutical companies. Another idea that the drug companies are not in favor of is to place a telephone number in ads, so consumers can call the FDA  to express their problems with a specific drug.

According to published reports, the chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell already is taking this issue seriously by calling a hearing on direct-to-consumer advertising. In a statement regarding this issue,  Dingell said, “Drug companies should know that they would be held accountable for inappropriate behavior and inaccurate representations made in their ads.” The hearing is expected to take place in a few weeks.

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Roche acquires Piramed for $160 million

BY Adam Kraemer

ZURICH , Switzerland Roche Holdings said it will buy U.K.-based biotech firm Piramed for $160 million in an attempt to strengthen its oncology and arthritis pipelines.

An additional payment of $15 million is due upon the commencement of Phase II clinical trials for the company’s oncology program, the Swiss company said.

The final transaction value will be adjusted by the net cash balance remaining upon closing. Regulators are expected to approve the deal in the second quarter of 2008.

Piramed focuses on the development of PI3-K inhibitors, which are known to play an important role in halting disease progression and in preventing resistance to chemotherapeutics in cancer cells. Pre-clinical studies have demonstrated their potential importance in treating inflammatory diseases such as rheumatoid arthritis, Roche said.

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