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Consumer Advocacy Group Denounces 21st Century Cures Act

Dangerous Drug Lawsuit

Some consumer health advocates are staunchly opposed to a new bill that was unanimously approved by the House Energy and Commerce Committee on May 21, 2015. H.R. 6 is the 21st Century Cures Act that is being touted by its proponents as being a bipartisan reform package to facilitate medical innovations for the betterment of patients.

However, Public Citizen, a well-known and highly regarded consumer watchdog organization, is strongly opposed to this measure. The group denounces the bill as little more than “snake oil,” stating that its passage into law would only lead to more reports of adverse events among patients, and quite possibly, more drug injury lawsuits filed against pharmaceutical and medical device companies.

Impact on approval of high-risk medical devices

One of the reasons why more lawsuits may result from this bill is Section 2222, which would give the FDA the authority to approve new high-risk medical devices on the basis of medical journal articles or case studies, which may involve uncontrolled studies of any number of study participants. This may discourage the FDA from requiring clinical testing for new medical devices, which may lead to the entry of potentially dangerous medical devices into the stream of commerce. This could open the door to serious injuries and perhaps death.

Additionally, section 2221 of the 21st Century Cures Act would enable medical device companies to make changes to products that have already been approvedwithout further documentation of safety or notifying the FDA of the changes. Public Citizen argues that this would essentially give medical device companies free rein to sell products such as hip implants and artificial heart valves without having to test them first to develop a safety profile.

Potential for dangerous drugs to enter the marketplace

Drug injury lawsuits often allege that the defendants failed to conduct sufficient clinical testing to establish patient safety. If the 21st Century Cures Act is approved, pharmaceutical companies would be allowed to fast-track new antibiotics and antifungals without subjecting them to later-stage trials. Furthermore, Public Citizen contends that the bill would facilitate rampant antibiotic resistance and place patients at risk of being harmed by drugs that may be ineffective or have serious side effects.

Questionable nature of reporting guidelines

Some plaintiffs who file lawsuits based on drug-related injuries claim that pharmaceutical companies unfairly influence physicians and use aggressive marketing tactics to promote their products. The Physician Payment Sunshine Act sets forth physician reporting requirements that mandate that physicians must report any fees or gifts received from medical or pharmaceutical companies. The 21st Century Cures Act would provide an exemption for these requirements, allowing drug and medical device manufacturers to avoid reporting gifts to doctors or speaking fees that may be construed as “continuing medical education” purposes.

Limited access to expensive medications

Another way in which the 21st Century Cures Act would harm patients according to Public Citizen is by restricting their access to expensive medications. They argue against the provisions of the bill that would prohibit the sale of generic medications for a longer period of time, which forces patients to purchase the more expensive brand name product.

  1. Public Citizen, Don’t Buy the Snake Oil: 21st Century Cures Would Reduce Safety of Medications and Devices,
  2., H.R.6 - 21st Century Cures Act,