Under Scott Gottlieb’s leadership as the head of the Food and Drug Administration, the FDA has focused on bringing more generic drugs to market to compete with pricier name-brand drugs and help lower prescription drug prices. Competition increases when generic drug and biosimilars are made available and, in turn, the price of patient’s prescription drugs comes down. That’s why it’s so important that the FDA is taking steps so patients have access to generic drugs and biosimilars more quickly. In a little over a year that Commissioner Gottlieb has been in office, he worked to clear out the backlog generic drugs waiting to be approved and is working hard to get biosimilars to market and in use faster and by more people. In July, the FDA approved a record number of generic versions of drugs — 126 drugs were approved in July alone, the highest monthly amount approved in the history of the generic drug program. In August, the FDA approved the first generic for the widely prescribed allergy treatment, Epipen — a huge step forward for children and others struggling with life-threatening allergies and further proof of the FDA’s commitment to providing greater access to “lower cost, safe and effective generic alternatives.” What’s more, the FDA introduced a Biosimilar Action Plan to further spur competition for expensive biologic drugs that are on the cutting edge for treating cancers and other hard to treat diseases. Commissioner Gottlieb has also spoken out about drug company abuses that keep generics and biosimilars from coming to market. For example, he called drug company tactics to deny samples for generic testing “unfair and exploitive” and launched a website to spotlight the worst offenders. He blasted a “rigged” contracting system that is impeding development and use of biosimilars and pledged action to address the problems. Commissioner Gottlieb is this month’s Patients for Affordable Drugs’ Price Fighting Hero for his achievements and the work underway at the FDA to stop unfair and exploitive drug company tactics that prevent less expensive generics and biosimilars from coming to market. ### Patients For Affordable Drugs’ Price Fighting Heroes is a new series highlighting heroes in the fight to lower prescription drug prices. We will honor patients, private sector leaders, policy makers, and elected officials who are advocating for patients and fighting for lower drug prices. In doing so, we hope to encourage others to join the fight and continue their good work. We plan to feature our heroes on our social media accounts and blog, lift up their stories in the media and honor them at a special event in 2019. |