PHARMACY

EPA sets up collection sites in eight states for used meds

BY Adam Kraemer

BUFFALO, N.Y. The Environmental Protection Agency, recognizing that trace amounts of pharmaceuticals are showing up in drinking water, has begun urging consumers living near any of the Great Lakes to bring their old medications to official collection centers.

The EPA is helping pay for more than 70 collection points in eight states that will take old medicine—along with electronic waste like computers, cell phones and televisions—from April 19 through April 27. The agency has set a goal of collecting 1 million pills during an Earth Day initiative aimed at the more than 30 million people who live around the Great Lakes, which are by far the largest source of fresh drinking water on the planet.

The collection sites are being established in New York, Illinois, Indiana, Michigan, Minnesota, Ohio, Pennsylvania and Wisconsin.

“We’re trying to raise public awareness on disposing of pharmaceuticals properly and we’ve had a very good response from communities on water districts. This is information that needs to get out there,” EPA spokeswoman Phillippa Cannon said Tuesday.

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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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