FDA Safety and Innovation Act

On July 9th, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (S. 3187).  Amazingly enough, this particular piece of legislation passed both the House and the Senate with overwhelming bipartisan majorities, a stunning thing in this day of endless bickering, dueling agendas and paralyzing quagmire in Washington.

So what is this law all about?  Its purpose is to help get safe and effective medical products to needy patients more quickly, while at the same time shoring up this country’s role as a leader in biomedical innovation.

If all goes well, and it should in this case, the legislation will see to a more timely review and assessment of new, innovative drugs and medical devices and funds what is termed the ‘new approval pathway’ for biosimilar biologics created by the Affordable Care Act (ACA).  The law will also see to the implementation of President Obama’s 2013 Budget to speed approval of lower-cost generic drugs. These are all programs vital to expanding patient access to more affordable medicines.

It took a lot of long hours and hard work by both the administration and Congress to put this law together, along with help and input from patients, doctors and the clinical sector, the medical devices and pharmaceutical industries, and many others.  Everyone worked together to provide the FDA with the tools and information it needed to continue to get drugs and devices safely to market while promoting ongoing research and innovation in the biomedical arena.  There is also the added benefit of promoting the jobs of those workers involved in device and drug development.

And there are other benefits, too.  There have been devastating drug shortages over the past several years and this legislation makes more tools available to the FDA to combat these shortages.  Manufacturers of some drugs will be required to notify the FDA if and when they experience events that could result in potential shortfalls.  The law also addresses the integrity of the drug supply chain, especially important in this era of globalized markets.  Further, there are incentives to design and develop new antibiotics, to see that medications for children are more appropriately tested and labeled, and to encourage the development of drugs for the treatment of some especially difficult, chronic or life-threatening diseases and conditions.

Expectations for this legislation are high, of course.  It is hoped that the next generation of medical products will be more affordable and even more effective – which is fine, as far as it goes.  A healthy, vibrant nation is a terrific goal.  We still need to do our part, though, in fact, now more than ever.  Technology has its (many) limitations, despite what the ad campaigns and marketing wizards insist on telling us.  Drugs have side effects, machines break down.  So, eat properly, get your exercise, join your community, hug your friends and family.  Walk the dog.  Play outside.  Be grateful – every day – for what you have already.


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