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The FDA last week defended its decision to not allow an agency expert to testify about his conclusions concerning a possible link between the use of some antidepressant drugs and an increased risk of suicide in young people taking the medications.
A ruling by the California Supreme Court last week upholding FDA warning labeling represents an important victory for the agency, GlaxoSmithKline and the industry at large, and it could set an important precedent.
All Rx drugs and certain OTC products would be required to include an FDA toll-free telephone number for consumers to report side effects, as well as a statement that the contact number is not intended for seeking medical advice, according to a proposed rule the agency issued last week.
The FDA has set its regulatory sights firmly on the dietary supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe, just one week after issuing its final rule banning supplements containing ephedra took effect.
In light of mounting concerns over the cost and availability of prescription drugs in the U.S., government officials and the pharmaceutical industry are facing intense pressure on the drug importation front. The spotlight on importation has grown particularly bright in recent months, as there has been a strong movement by American consumers, as well as states and municipalities, to use Canadian internet pharmacies to fill their Rx drug needs. Advocates for the pharmaceutical industry have argued that importation isn’t the answer to affordability and accessibility concerns and will only leave the U.S. more vulnerable to safety and counterfeiting dangers. Many state and local governments, meanwhile, are aggressively pursuing importation plans to provide residents with easier access to low-cost Canadian drugs much to the dismay and opposition of federal officials and the U.S. drug industry. On the other side of the border, Canadian drug suppliers and pharmacies have started expressing concerns about the Canadian drug supply, arguing that the increase in prescription orders from the U.S., combined with increasingly tight supply restrictions being imposed by some pharmaceutical companies’ supply policies will prevent Canadian demand from being met. These concerns have brought forward the HHS Drug Importation Task force, chaired by U.S. Surgeon General Richard Carmona, to explore how drug importation might be conducted safely and its potential impact on the health of American patients, medical costs and the drug development pipeline.
A bipartisan group that includes some of the Senate's most powerful and influential members yesterday introduced reimportation legislation its sponsors contend provides for a method of securing safe and effective Rx drugs from other countries.
Approving a generic biologic would require the FDA to rely on an innovator firm’s trade secret data covering the product’s manufacturing process — something that is prohibited by law, argues biotech firm Genentech.
The FDA is establishing a public docket to get input on activities that could reduce existing hurdles in medical product design -- including drug development -- as part of the "critical-path" initiative it announced last month.
The FDA has issued a proposed rule that would require all Rx drugs and certain OTC products to include an FDA toll-free telephone number for consumers to report side effects, as well as a statement that the contact number is not intended for seeking medical advice.
Just one week after its final rule banning dietary supplements containing ephedra took effect, the FDA has settled the cross hairs of its regulatory sights firmly on the rest of the supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe.