The number of children receiving prescriptions for antidepressants dropped following warnings from the FDA about the increased risk of suicidal behavior associated with the drugs, according to a new study.
An HIV/AIDS healthcare provider has filed a lawsuit against Pfizer, saying its marketing campaign for Viagra promoted recreational use of the drug and contributed to increased incidence of sexually transmitted diseases (STDs), including HIV.
Drugmakers are increasingly turning to off-label promotions and direct-to-consumer (DTC) advertising in an effort to increase or defend market share. At the same time, the government, activists and academics are stepping up their criticism of those activities. The Department of Justice has been especially aggressive in prosecuting off-label promotions. Some experts say that may have a chilling effect on the industry; others call for reform to ensure the law is being enforced consistently. While a congressional committee has begun investigating the practice, the FDA warns that legislative interference may limit doctors’ ability to treat their patients. Congress is also taking a look at changing how the agency regulates DTC ads, although some observers doubt the efforts will be successful. One proposal, spurred by a report from the Government Accountability Office on drug industry advertising spending, is to ban all DTC ads for newly approved drugs. A group of academics has gone one step further, concluding that the ads have limited value other than increasing drugmakers’ profits. The FDA, for its part, says it does not have the funding to review the ads it currently receives and is proposing the industry help pay for the system. This issue of The Food & Drug Letter looks at these and other recent developments and how they affect companies’ efforts to market their products.
A new Medicaid rule being proposed by the Centers for Medicare & Medicaid Services (CMS) could discourage generic drug use and should be amended to reflect actual acquisition costs for retailers that fill prescriptions with generic drugs, a pharmacist group said.
The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.
FDA staff say the Critical Path Initiative (CPI) is in trouble, with insufficient funding leaving employees working on the program during their off hours. The agency is now looking for increased funding through appropriations and user fees to address the problem.
While recent Centers for Disease Control and Prevention (CDC) data show an increase in the number of adolescent suicides since black box warnings were added to some types of antidepressants, there may not be enough data to link the two, a government source says.
Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA’s drug safety system, has seized on a recent agency report as evidence that the agency’s postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.