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FDA Updates Some Standards
Staff Reporters
According to the Wall Street Journal, December 11, 2008, prescription drug makers updated their voluntary standards for direct-to-consumer advertising to make the ads more informative. But, the measures stop short of changes sought by government and industry critics.
The FDA and “Actors”
The companies said they will halt advertising that includes promoting prescription drugs for non Food and Drug Administration [FDA] approved uses; or using actors as physicians. The guidelines say celebrity endorsers shouldn’t say they use a drug – unless they actually use it.
PRMA Industry Trade Group
The Pharmaceutical Research and Manufacturers of America [PRMA], the industry trade group that issued the standards, reported their aim was to address the concerns of doctors, and Congress while continuing to keep patients informed about valuable treatments. Critics said the changes didn’t go as far as advocated by a panel on drug safety from the Institute of Medicine [IOM], including making company’s wait two years before advertising a prescription drug directly to consumers so that effects can be better understood. Critics also said that television ads should include the phone number at the FDA for patients to call to report side-effects.
Assessment
Under the voluntary standards, only print-ads would include the phone number.
Conclusion
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Filed under: Drugs and Pharma, Quality Initiatives, Risk Management, Surveys and Voting | Tagged: D2C drugs |
The Leading Business Education Network for Doctors, Financial Advisors and Health Industry Consultants 
The Supreme Court just ruled that FDA approval of a drug is no protection from lawsuits in state courts and could make drug makers more cautious about safety issues leading them to halt development of some medicines and even pull others off the market.
Drug industry analysts said the ruling, upholding a $6.7 million jury award against Wyeth, will make big-pharma scrutinize safety issues of all experimental drugs in development, as well as existing products. Any thoughts?
Ann Miller; RN, MHA
http://www.HealthDictionarySeries.com
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The “Bad-Drug” Ad Program
The FDA just launched a new program to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading. And, the agency gave the outreach effort an apt name: “The Bad Ad Program”
http://www.fiercepharma.com/story/fda-acts-faster-drug-ad-missteps/2010-02-03?utm_medium=nl&utm_source=internal
http://www.fiercepharma.com/press_releases/fda-bad-ad-program-help-health-care-providers-detect-report-misleading-drug-ads?utm_medium=nl&utm_source=internal
Key points and issues of the program:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/DrugMarketingAdvertisingandCommunications/ucm211498.htm
http://www.reuters.com/article/idUSTRE64A46C20100511
Any other thoughts?
Mark
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Mark,
Will some DTC foes use the FDA’s new “Bad Ad” program to crusade against the very idea of consumer advertising for drugs?
http://adage.com/article?article_id=144039
That’s what some industry-watchers predict in an Advertising Age analysis of the agency initiative.
http://www.fiercepharma.com/story/fda-acts-faster-drug-ad-missteps/2010-02-03?utm_medium=nl&utm_source=internal
What do you think?
Fred
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