FDA Mulls Plan For How Tweets Promoting Prescriptions Drugs Should Inform About Side Effects
The Food and Drug Administration also issues a rule aimed at curbing the use of citizen petitions for generic drugs or biosimilars. Some agency officials say the practice is used to slow down the approvals process.
FDA To Study How Promotional Tweets For Drugs Should Convey Side Effects
After years of mulling over social media uses, the Food and Drug Administration plans to study the whether a tweet promoting a prescription drug with a link to risk information is an acceptable way to reach consumers. The plan is the latest in an ongoing, but drawn-out, effort by the agency to provide the pharmaceutical industry with guidelines for using social media to promote medicines. The FDA, in fact, two years ago issued a draft guidance about the use of social media platforms, such as Twitter, but never actually addressed if drug makers could employ links to convey important side effect data. (Silverman, 11/9)
FDA Issues A Rule To Block Drug Makers From Abusing Citizen Petitions
After years of concern, the Food and Drug Administration issued a rule on Tuesday that limits the use of citizen petitions to delay approval of generic drugs or biosimilars. The move comes after repeated complaints by agency officials that many petitions generally do not raise valid scientific concerns and appear to have been filed solely to delay rival medicines. The rule, which goes into effect this coming January, comes after the FDA issued new guidelines five years ago that were intended to limit such petitions. Congress, however, requires the FDA to respond to most petitions within 150 days, but agency officials have complained this creates an unnecessary problem. (Silverman, 11/9)