FDA to Learn About Drug Side Effects from Patient Website Data
The FDA has reached an agreement with a website that collects patient data and feedback, which may help the federal drug regulatory agency evaluate medical information supplied by hundreds of thousands of patients, potentially learning about real-world drug risks.
The collaborative agreement, between the FDA and PatientsLikeMe, was announced in a June 15 press release and will provide the agency access to data generated by 350,000 of the site’s members. The two groups indicate that this data will assist the FDA in post-market surveillance of drugs that are already on the market.
The FDA struggles to keep up with post-market surveillance data, which is used to detect recurring adverse events linked to recently approved drugs. In many cases, drugs were approved with minimal clinical trials and much of the information on the safety and effectiveness of a drug comes after the public has already been using it.
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According to the press release, drug companies often provide limited information and small populations, sometimes just a few hundred patients, from which the FDA is supposed to determine a drug’s risks.
“Most clinical trials only represent the experience of several hundred or at most several thousand patients, making it impossible to anticipate all the potential side effects of drugs in the real world. Patient-generated data give a more complete picture about a drug’s safety by providing a window into patients’ lives and healthcare experiences over time,” PatientsLikeMe Co-Founder and President Ben Heywood said in the press release. “We’re very encouraged by the FDA’s action to evaluate newer sources of data to help identify benefits and risks earlier.”
PatientsLikeMe allows members to interact with others with similar conditions and diseases, share experiences with drugs and volunteer medical data which can be used by industry, researchers, non-profit groups and now the FDA to get a better picture of the drug’s safety profile and provide better services. Patients can also learn what to expect or how to cope or avoid certain adverse events linked to drugs and medical procedures from other patients’ experiences.
FDA Post-Marketing Surveillance Problems
According to a study published in the Journal of the American Medical Association (JAMA) in July 2013, many drug companies fail to follow through on post-marketing surveillance commitments made to the FDA at the time their products were approved, without any real risk of being penalized. Researchers indicated at the time that more than 40% of postmarketing studies for all drugs had not even been started, causing a lack of data on many new medications.
That study also indicated that the rate of completion for post-marketing studies that the companies actual start is extremely low. In 2011, only 12% of studies had been completed, a “jump” from the under 7% that had been completed in 2007. The trend for completion has improved since 2007, however the rate of completion still leaves more than 85% unfinished.
Serious side effects associated with prescription drugs are often not discovered until after a medication has been approved and is available on the market, which highlight the importance of drug makers continuing to follow up with studies once the medications are being used by thousands or even millions of people.
A 2006 report from the Office of Inspector General found that drug companies were seriously deficient in completing post-marketing studies and indicated that the FDA lacked the authority to enforce completion. Congress passed the FDA Amendments Act (FDAAA) in 2007, which required post-marketing studies as part of the drug approval process, and offered the FDA more latitude in mandating compliance with completing the studies.
Critics have suggested that the FDA is failing to crack down on pharmaceutical companies, which are flaunting compliance with post-marketing study requirements, noting that issuing warning letters, initiating litigation for “significant failures,” and conducting seizures and injunctions are all within the FDA’s legal power, and pointing out that the agency has made little use of that enforcement power.
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