Sen. Pennycuick Legislation to Help Bring New Life-Saving Treatments and Devices to Market Quicker Passes Senate

HARRISBURG - Today, the Pennsylvania Senate unanimously passed Senate Bill 1206 introduced by Sen. Tracy Pennycuick (R-24) to help get new life-saving treatments and devices to market more quickly.

Senate Bill 1206 allows companies to gain temporary approval under Pennsylvania's virtual manufacturers' law, so that once federal approval is granted, these companies can quickly move forward without having to clear additional administrative roadblocks.

"Making new treatments and devices available more quickly matters for patients waiting for these new life saving therapies. It matters for start-up companies trying to survive the long and expensive path from research to commercialization, and it matters to companies looking to invest in Pennsylvania," said Pennycuick.

Under current law, a pharmaceutical or medical device manufacturer must first complete the lengthy federal FDA process before it can even begin the state licensure process in Pennsylvania. The process creates unnecessary delays after a company has already invested years of research, clinical work and capital into bringing a new treatment or technology closer to market.

Senate Bill 1206 does not weaken existing safety standards nor bypass the FDA approval process. In addition, it does not allow unapproved products to enter the market and keeps the FDA as the gatekeeper for safety and effectiveness.

"Pennsylvania is a national and global leader in the life sciences industry with world-class universities, cutting-edge research institutions, skilled workers, and a growing base of biotechnology, pharmaceutical, and medical device companies. But in this industry, states are competing aggressively for investment, jobs, and the next generation of medical breakthroughs. If Pennsylvania wants to win that competition, our regulatory structure must remain on the cutting edge", added Pennycuick.

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