The key question may be how FDA should assess neutrality of prescription drug maker presentations of information about side effects and effectiveness.

FDA Taking Comments on Rx Ads' Side Effects Content

The requirement that direct-to-consumer TV and radio ads for prescription drugs present information about side effects and contraindications in a clear, conspicuous, neutral manner was in the Food and Drug Administration Amendments Act of 2007.

FDA asked Monday for public comments on how makers of prescription drugs should explain the side effects and contraindications in their direct-to-consumer TV and radio ads for such drugs. The Food and Drug Administration Amendments Act of 2007 required that they communicate the information in the ads in a clear, conspicuous, neutral manner, and the key question may be how FDA should assess neutrality.

FDA said it will accept comments until June 28. They may be submitted, identified by Docket No. FDA-2009-N-0582 and/or RIN 0910-AG27, via www.regulations.gov.

The current regulations on prescription drug ads say they must contain "a true statement" of certain information, including "information in brief summary relating to side effects, contraindications, and effectiveness." The 2007 law added a provision that "in the case of an advertisement for a drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner." The law gave the HHS secretary 10 months from its enactment to set standards for determining whether an ad's major statement fulfills that requirement.

FDA looked to other agencies' rules, including some from the Federal Trade Commission, Securities and Exchange Commission, and Department of Transportation.

FDA said in the Monday proposed rule that it is not aware of any previous standard or regulation that defines "neutral manner" in the context of required disclosures; the agency said it believes "neutral manner" means "unbiased manner" and has proposed its standards accordingly.

Product Showcase

  • Full Line of Defense Against Combustible Dust Nilfisk

    Nilfisk provides a comprehensive range of industrial vacuums meticulously crafted to adhere to NFPA 652 housekeeping standards, essential for gathering combustible dust in Class I, Group D, and Class II, Groups E, F & G environments or non-classified settings. Our pneumatic vacuums are meticulously engineered to fulfill safety criteria for deployment in hazardous surroundings. Leveraging advanced filtration technology, Nilfisk ensures the secure capture of combustible materials scattered throughout your facility, ranging from fuels, solvents, and metal dust to flour, sugar, and pharmaceutical powders. Read More

  • The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi gas detector that runs continuously for three years without being recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Its durability enables the detector to withstand the harshest treatment and environments, hence earning it an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as the GCT External Pump. Visit gascliptech.com for more information. Read More

  • SECUPRO MARTEGO

    FOR HIGHEST DEMANDS. A cutting tool in which function and design go hand in hand. Meet the SECUPRO MARTEGO, our prize-winning squeeze-grip safety knife with fully automatic retractable blade for safety. • Ergonomically friendly trigger mechanism to engage the blade • Durable body made of aluminum • Safer alternative to fixed blade utility knives for general cutting tasks • 9 mm Cutting depth • Easy, tool free blade change Dimensions: L 6.10" L x 0.71" W x 1.91" H Weight: 3.70 oz Cutting Depth: 9 mm Read More

Featured

Artificial Intelligence

Webinars