PHARMACY

FDA regulators set to start in China pending final approval

BY Adam Kraemer

WASHINGTON Food and Drug Administration plans to open an office in China—as part of a change in strategy following product safety problems in Chinese imports that prompted several health scares and have been linked to some deaths—are proceeding on schedule. Health and Human Services Secretary Mike Leavitt said this week that only final approval from Beijing is needed before regulators start work there next month.

“In the past, the United States and many other countries have employed a strategy of standing at the border trying to catch things that aren’t safe,” Leavitt said in an Associated Press interview during a visit to Singapore.

U.S. regulators have recently recalled a number of contaminated products made in China: toothpaste, pet food, the blood thinner heparin and others. Heparin, a commonly used blood thinner, has been linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

Christopher Hickey, current director of the Asia and the Pacific office at HHS will head up the China office, Leavitt said.

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PHARMACY

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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