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Faster Drug Approval Under 21st Century Cures Act Could Increase Medication Injuries

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On July 10th, a health bill called the 21st Century Cures Act passed the U.S. House of Representatives, promising regulatory changes for Prescription Pad With a Stethoscope and Pill Bottledrug approval and increased funding for the National Institutes of Health. If the bill becomes law, millions of Americans may get faster treatment for serious health conditions, but many groups are concerned that speed is being prioritized over safety.

If it is approved, the 21st Century Cures Act could lead to an increase in medication injuries due to:

  • Faster approval. The bill was partly created to quicken the slow drug approval process by the U.S. Food and Drug Administration (FDA). The FDA has strict standards for all new medications, including rigorous clinical trials, which the drugs must pass before they can be prescribed to patients. However, supporters of the 21st Century Cures Act says that the FDA’s regulatory process is outdated, and that the bill would remove many of the hurdles that new medications (and its creators) fuse.
  • Relaxed standards. The FDA relies on information collected in early patient testing to gauge the effectiveness and potential side effects of new medications. These clinical trials may run for a year or longer and involve hundreds of patients in order to collect accurate information. Under the new bill, drugs could be approved using more flexible clinical trials, such as using a smaller number of patients or a shorter time period. The bill specifically mentions quickening approval for new antibiotics, as current antibiotics are becoming less effective due to overuse.
  • Real-world data. The bill suggests that the FDA study the effects of medications on real-world patients, using data from doctors’ practices or disease registries, as a way to approve new uses for drugs. The bill also allows the FDA to measure the effect of a medication without regard for patient improvement, such as when a medication causes a patient’s tumor to remain unchanged rather than shrinking.

What Should I Do If I Suspect a Medication Caused My Injury?

If you or someone you know suffered severe side effects from a medication, you could be owed thousands of dollars in compensation for your medical bills. At Wayne Wright LLP, we offer free consultations to all new clients, and you will pay no attorney fees unless we win your case. Call us today at 800-237-3334 to have us examine the details of your case.

 

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