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New legislation could change how drugs and medical devices are approved

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

A new proposal is gaining momentum and may become law. Here are some highlights.

The 21st Century Cures Act is swiftly moving through legislative channels. The law was approved unanimously in committee with a vote of 51 to 0 and passed the House of Representatives with a vote of 344 to 77. The bill is sponsored by Representative Fred Upton of Michigan and Diana DeGette of Colorado and appears to be making its way towards becoming law. As a result, it may be wise to have a basic understanding of the provisions and how they could impact future medical care.

More on the proposal

A recent article in The Hill notes that the legislatures behind the proposal worked with “scientists, policymakers, advocates and patients to find ways to speed the process from a promising scientific discovery in the lab to development and delivery of real-world treatments for the entire gamut of known health conditions, including rare disease.”

The proposal claims to modernize federal regulatory process in the following ways:

  • Funds. If passed, the National Institutes for Health (NIH) and Food and Drug Administration (FDA) would receive an increase in funding. The increase translates to $8.75 billion dollars over a span of five years that will lead to funding for research centers as well as creation of an NIH Innovation Fund. An additional $550 million will be provided to help fund staffing and other resource needs for the FDA.
  • Approval. The proposal would also make changes to the approval process for medical devices. Health News Review recently ran a piece examining this portion of the bill, noting “breakthrough” medical devices could receive approval from the FDA based on “anecdotal evidence, rather than scientific studies” when the “need outweighs the risk” of a more thorough review.

Those who oppose the legislation argue it could have a negative impact on the safety of medical products available on the market. A recent article in the New England Journal of Medicine discussed the issue, noting that over two thirds of drugs currently approved are the result of studies that last six months or less. The physician authoring the article stated the short study period currently in force could pose problems for medications that are designed for lifetime use. The 21st Century Cures Act would instruct the FDA to “consider nontraditional study designs and methods of data analysis to further speed approvals.”

A group of healthcare providers, clinical researchers, public health experts and consumer advocates have also come out against the proposal, voicing concern that it “fails to ensure a comprehensive and scientifically based approach that supports patients’ access to affordable treatments.” Instead, the group argues that the proposal as written allows for “unsafe and ineffective drugs and medical devices to enter the market while further limiting access to effective medicines for patients.” The group, Public Citizen, a consumer rights advocacy group, specifically points to concerns regarding the safety of medical devices, antibiotics and antifungals along with concerns that provisions within the proposal would lead to weakened reporting requirements allowing for influence of pharmaceutical and medical device companies on physicians without full disclosure.

Medical malpractice, medications and medical devices

Regardless of the fate of this particular bill, it brings attention to the review process used for medications and medical devices. If injury results from the use of these medical devices and medications, compensation may be available to the victims. This compensation can help cover the high cost of additional medical treatment and lost wages. Contact an experienced prescription drug attorney to discuss your legal options.

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