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PhRMA has found an unlikely ally in its push to get the FDA to publish a final rule on paper pedigrees: consumer groups, who also have told the agency it should implement the final rule, but with a different objective in mind.
Rep. Henry Waxman (D-Calif.), the ranking minority member on the House Government Reform Committee, has fired off another letter to HHS Secretary Tommy Thompson threatening legal action if he does not respond to previous requests for information related to the cost estimates of the new Medicare law (DID, March 3, Page 4).
Days after receiving a General Accounting Office (GAO) report that concluded the Bush administration had not violated federal law in its print and TV advertising for the new Medicare program, a U.S. senator is asking the agency to investigate another advertisement.
The FDA and the HHS Task Force on Drug Importation will convene a public meeting April 14 for industry, the public and other stakeholders to submit comments and information for a study on the feasibility of importing prescription drugs from Canada.
Several House members have asked the HHS inspector general to investigate reports that the chief actuary for the Centers for Medicare & Medicaid Services (CMS) was ordered to withhold information — under threat of reprimand or termination — related to the cost of the new Medicare law from Congress.
HHS is requesting proposals from industry to develop, test and manufacture a new anthrax vaccine to protect the public against a bioterrorist attack in which anthrax spores are released into the environment.
After issuing a final rule earlier this year banning dietary supplements containing ephedra, the FDA focused its efforts yesterday on taking the steroid precursor androstenedione, also known as andro, off the market by issuing warning letters to 23 companies manufacturing and distributing andro products.
The FDA needs to clarify the distinction between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance to ensure drug manufacturers submit the appropriate data and avoid delays in product development, according to industry comments received by the agency recently.
Irritated that a previous request for information on Medicare cost estimates has not been answered, several House members yesterday fired off another letter to HHS Secretary Tommy Thompson and invoked the little-known "Seven-Member Rule," demanding that the secretary supply the information by March 15.
The National Institutes of Health (NIH) recently informed women involved in an estrogen treatment study to stop taking their pills due to an increased risk for stroke associated with the treatment, NIH announced yesterday.