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Senior management employees and professional staff at the National Institutes of Health who manage grants should not take consulting or speaking fees from drugmakers, according to the recommendations of a blue-ribbon panel established by NIH Director Elias Zerhouni.
The chairman of the Senate Finance Committee has asked the FDA to provide him with detailed information about its contract with Columbia University to evaluate reported adverse events as part of his ongoing investigation into allegations that the agency withheld information about a possible link between child suicide and antidepressant use.
The political firestorm ignited by the FDA’s decision not to approve OTC status for an emergency oral contraceptive earlier this month could intensify today with the expected introduction of a House bill directing the agency to conduct a formal review of the process it used to make its decision.
A bill approved by the Senate late Tuesday to end European trade sanctions against U.S. businesses would extend by 18 months a research and development (R&D) corporate tax credit set to expire June 30, according to an official at a manufacturing trade group whose members include PhRMA and the Biotechnology Industry Organization.
As part of an ongoing investigation into allegations that the FDA withheld information about a possible link between child suicide and antidepressant use, the chairman of the Senate Finance Committee has asked the agency to provide detailed information about its contract with Columbia University to evaluate reported adverse events.
The U.S. Patent and Trademark Office (PTO) wants to let third parties – including generic drugmakers — challenge the validity of new patents before PTO administrative law judges, thus avoiding the need to battle patents later in federal courts.
Two powerful U.S. senators sent letters last week to 19 drug companies asking for detailed pricing information for eight classes of drugs, saying they are concerned that drug manufacturers may be using an exception to Medicaid price-reporting requirements that could be resulting in hundreds of millions of dollars in payments.
U.S. drugmakers — especially brand companies — would be able to use several options available to them to minimize the effects of changes in prescription drug importation policy on U.S. pharmaceutical prices, including gaining FDA and foreign-government cooperation in limiting the trade practice, according to a report from the Congressional Budget Office (CBO).
Drug prices being quoted for the new Medicare discount drug cards are still far higher than Canadian prices or those negotiated by the federal government, according to a study by the minority staff on the House Government Reform Committee.
Bush administration officials likely violated federal law by allegedly trying to prevent the chief actuary at the Centers for Medicare & Medicaid Services (CMS) from releasing cost estimates on last year’s Medicare drug bill, according to the Congressional Research Service (CRS).