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Recently, congress voted on bill that promises to speed up the drug approval process. The $6.3 billion 21st Century Cures Act was approved by the House of Representatives this past November. It received Senate approval and President Obama signed it into law on December 13, 2016. Many industry analysts see this as a potential “game changer” for new product launches, but like most bills, it has both positive and negative implications. The bill was backed by many patient groups and industry organizations including PhRMA, and AdvaMed.

An early Christmas Present for the Pharmaceutical Industry?

$500 million of the funding will go towards the FDA to approve drugs for life-threatening infections based on test results from a smaller-than-normal patient populations according to the New York Times. Additionally, the provisions would allow the FDA to use data summaries instead of more detailed studies to approve existing drugs for new uses. This allows drug makers to promote off-label uses of their drugs to insurance companies, vastly expanding the markets for these drug products while bypassing FDA scrutiny. This is perceived as a green light for the pharmaceutical, biotech and medical device industries.

Currently, Big Pharma generates an estimated $325 billion annually in the U.S., and medical device companies about $150 billion. Under the new bill, they stand to save billions to bring new drugs and devices to market. Additionally, advances in novel formulation and delivery technologies have provided many commercial opportunities for drug makers to expand their portfolios of drug and medical device products earlier on in the patent lifecycle. Furthermore, drug bioavailability enhancement strategies have paved the way for increasing molecule time-to-market solving many potential product issues later down the line. This means 2017 and beyond could well see a surge in approved medical device and drug products, propelling the industry even further. If interested to learn more about novel bioavailability enhancement strategies currently being deployed by some of the industry’s major, check out our Global Drug Bioavailability Enhancement Summit taking place this January in New York.

Potential Controversy for the Industry?

Republican U.S. Rep. Mike Fitzpatrick of Pennsylvania voted against the bill and quoted “The 21st Century Cures Act will help accelerate the discovery and development of new treatments for patients…However, I voted against the bill because it fails to protect patients against dangerous medical devices.”

One of the main gripes with the law is an unnecessary new fast-track pathway for FDA approval of antibiotics based on non-clinical data as well as small, early-stage clinical trials (Section 2121). Antibiotics could be approved based on animal data and modeling which doesn’t always translate to effectiveness in patients.

An example previously of fast-tacked approvals negatively impacting the industry is Merck’s Vioxx, a painkiller and arthritis drug the FDA approved in 1999. Vioxx was pulled off the market in 2004 after it was shown to raise the risk of heart attacks. By then, according to research in the British medical journal Lancet, 88,000 Americans had heart attacks from taking Vioxx, 38,000 of them fatally. Some argue that the 21st Century Cures Act would better serve patients if it had focused more on improving and reforming the drug and medical device approval processes, instead of weakening them. However, industry maintains the act will truly advance health outcomes in the long-run. 

Looking Forward

2017 proves to be a very interesting year within the drug and device approval arena with many potential blockbusters becoming available, some potentially sooner. For more information regarding drug bioavailability enhancement strategies, click here.

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