The FDA has approved Entereg® (alvimopan) to speed the restoration of normal bowel function after intestinal surgery.

However, the approval comes with a Risk Evaluation and Mitigation Strategy (REMS) to be sure that the benefits of using Entereg outweigh any potential risks.  Under the REMS, the drug can only be used only in hospitals for inpatients.  Hospitals that use it must be certified and materials developed for the health care professionals who administer it.  Its effectiveness must be regularly assessed. Read the rest of this entry »

Today, the Senate passed the FY 2008 supplemental appropriations bill for military operations abroad by a vote of 70 to 26. The Senate also passed a separate bill which provides supplemental funding in FY 2008 for domestic programs by a vote of 75 to 22. This bill includes $400 million for NIH and $275 million for the FDA. The two bills will be combined before any further activity takes place.

The House’s current FY 2008 supplemental appropriations bill does not include the emphasis on domestic programs. This is due largely to the fact that the White House has stated it will veto any supplemental funding legislation that doesn’t focus exclusively on military spending. The House and Senate will have to negotiate a final, compromised package to send to the White House after the Memorial Day recess.

Click here for the Roll Call Vote

House Energy and Commerce Committee Chair, John Dingell (D-MI) and Oversight Subcommittee Chair, Bart Stupak (D-MI) sent letters to Johnson & Johnson, Merck, Schering-Plough and Pfizer asking them to stop using “misleading and deceptive” direct-to-consumer advertising.

Dingell in a statement said, “Marketing department leaders have failed to commit to reducing misleading and deceptive ads, so we’re now asking the CEOs to make this agreement.” Stupak said, “We intend to make certain that drug companies market their product properly in order to protect American consumers from manipulative commercials designed to mislead and deceive for profit.”

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The House Energy & Commerce Subcommittee on Oversight convened a hearing May 8th to address Direct to Consumer (DTC) drug advertising by Johnson and Johnson, Pfizer and Merck Schering-Plough. C3 first raised questions in summer 2007 about Procrit® DTC advertising that ran from 1998 to 2005. Procrit is an anemia drug sold by Ortho Biotech, a subsidiary of Johnson and Johnson.

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In a letter written to Congress, Andrew Von Eschenbach, Food and Drug Administration (FDA) Chief, admits the agency needs an immediate infusion of $275 million.

Von Eschenbach’s request was made to Senator Arlen Specter (R-PA), Member of the Senate Appropriations Committee, in a letter.

Presidential appointees rarely diverge so forcefully from the President’s own spending plans, or at least avoid doing so in writing. Dr. von Eschenbach’s action surprised agency observers and was taken as perhaps a sign of the President’s waning influence in the closing months of his presidency (The New York Times, May 14, 2008).

Earlier this year, President Bush requested Congress to appropriate $1.77 billion to the FDA in FY 09. This includes an increase of $50.7 million over FY 08. This increase is not even enough to cover salary increases at the agency.

The FDA has been plagued with criticism for approving contaminated food and drugs and just recently came under attack for not properly policing the Direct to Consumer Advertisements used by pharmaceuticals companies.

Last week, Senator Herb Kohl (D-WI) offered an amendment to the FY 08 Emergency Supplemental Appropriations bill that would increase funding for the FDA by $275 million.

Advocates for increased food and drug oversight said they were thrilled with Dr. Von Eschenbach’s letter. “We are one step closer to an FDA that has the resources to serve the needs of American consumers,” said Caroline Smith DeWaal, Food Safety Director for the Center for Science in the Public Interest (The New York Times, May 14, 2008).