Law propsed to increase reporting of side effects

Discussion in 'General Parenting' started by Sara PA, Apr 2, 2008.

  1. Sara PA

    Sara PA New Member

    TV drug ads should list FDA hotline, lawmakers say

    The information would allow consumers to report serious side effects from prescription medication.

    By Ben DuBose, Los Angeles Times Staff Writer
    4:30 PM PDT, April 2, 2008

    WASHINGTON -- Citing a new Consumer Reports poll, two members of Congress urged the Food and Drug Administration on Wednesday to mandate that all television advertising for prescription drugs include information for consumers to report serious side effects to the agency.

    The poll found that 16% of respondents who had taken a prescription drug had experienced a side effect serious enough to send them to the doctor or hospital, but only 35% were aware that such side effects could be reported to the FDA.

    The FDA "is failing to serve its most vital supervisory responsibility," said Rep. Rosa DeLauro (D-Conn.), who chairs a House subcommittee with oversight of the agency. "The more we know about serious drug side effects, the more we can do."

    Through a program known as MedWatch, the FDA is responsible for tracking side effects from prescription and over-the-counter medication. It uses the reports to detect problems with drugs. But agency officials estimate they learn about fewer than 1 in 10 drug reactions.

    The poll results reflected that statistic, with 7% of respondents naming the FDA as a place where they would report a serious drug side effect.

    Consumers Union, the nonprofit organization that publishes Consumer Reports, sent the FDA a petition with more than 55,000 signatures requesting that a toll-free number and website address be included in television drug advertisements to make it easier for people to report side effects.

    "We have received the petition and are in the process of reviewing it at this time," said FDA spokeswoman Rita Chappelle.

    In FDA-related legislation passed last year, Congress required that contact information for the agency be included in all print drug ads and called for an FDA study to be completed by the end of last month to assess whether a similar requirement was needed for television ads. Chappelle said the study was still in progress.

    In the poll, television was identified as the medium where consumers were most likely to be exposed to a prescription drug ad. Of respondents who had recently seen at least one such ad, 98% said they had seen it on television; 59% said they had seen it in print.

    "We're working with and pushing the FDA," said Rep. Jan Schakowsky (D-Ill.), who serves on a House subcommittee on consumer protection. "The interest and signatures from consumers certainly help."

    In the poll, 87% of respondents supported such legislation, saying television ads should be required to contain FDA contact information.

    "Clearly, consumers want to know how to report serious drug side effects to the FDA, and they think drug advertising is an ideal way to do that," said Liz Foley, campaign coordinator for Consumers Union.

    "What better way for the FDA to let consumers know how to report serious problems with their medications than putting a toll-free number and website in all those drug ads we're bombarded by each day?" Foley asked.
  2. Steely

    Steely Active Member

    This is really good news. I hope all the information can be accurately disseminated to the public. Thanks for the info.
  3. gcvmom

    gcvmom Here we go again!

    I'm all FOR this proposal. I had no idea that the FDA tracked this info. There are a number of occasions where we've had bad reactions to medications and either had to go to ER or doctor's office, but I figured that was as far as the info could or would go. I'm sure most docs are too busy to report every unusual incident with medications.
  4. Christy

    Christy New Member

    A good idea, let's hope it works!