PHARMACY

FDA launches Web site to educate on DTC ads

BY Alaric DeArment

ATLANTA The Food and Drug Administration has launched a Web site to improve people’s understanding of direct-to-consumer advertising of prescription medications, the non-profit group EthicAid announced Friday.

The FDA launched the site, “Be Smart About Prescription Drug Advertising,” in partnership with EthicAd.

“People are often confused about DTC advertising, which is one of the most controversial areas of pharmaceutical marketing,” EthicAd executive director Michael Shaw said. “The FDA’s new web site helps clarify the issues by outlining the different types of DTC advertising, explaining what information people should expect to see in DTC ads, and what additional information they should seek out about advertised products.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?
PHARMACY

FDA increases drug warnings for TNF blockers

BY Alaric DeArment

WASHINGTON A risk of fungal infection has prompted the Food and Drug Administration to call on four drug makers to strengthen warnings on some of their products.

Johnson & Johnson’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab), Amgen’s and Wyeth’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol) are the drugs affected after the FDA reviewed 240 reports of the respiratory fungal disease histoplasmosis in patients using the drugs. Of the 240 patients, 45 died from the disease, whose symptoms resemble those of the flu.

The drugs belong to a class of drugs that block tumor necrosis factor, which normally helps the body fight cancer but is sometimes overproduced, leading to diseases such as arthritis and Crohn’s disease.

“Amgen and Wyeth are committed to the safety of patients,” the companies said in a jointly released statement Friday. “Both companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports from controlled and open-label clinical trials and patient registries, as well as reports received from health care professionals and patients. Both companies work with regulatory agencies to update the label periodically as appropriate based on emerging information.”

Amgen, they stated, will work with the FDA to finalize and communicate revised product labeling for Enbrel to both physicians and patients.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?
PHARMACY

FDA posts first quarterly drug safety report

BY Alaric DeArment

WASHINGTON The Food and Drug Administration has posted its first quarterly report on drugs under review for possible safety issues, the agency announced Friday.

The drugs are identified based on a review of reports in the FDA’s Adverse Event Reporting System and are listed under the Food and Drug Administration Amendments Act of 2007, which requires the FDA to inform the public of new safety information or potential signals of serious risk, based on reviews of AERS.

But, the FDA cautioned, a drug’s appearance on the list doesn’t mean it definitely carries the risk only because the FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

Please click here to view the full list of drugs.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

POLLS

Which area of the industry do you think Amazon’s entry would shake up the most?