As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.” The hearing notice, to be published in the Federal Register on July 25th (see here), notes that the Agency has determined that a public hearing is the most effective way for it to hear from a diverse and broad group of stakeholders, from patients and health care providers to manufacturers and professional organizations. Continue Reading Biosimilars Action Plan Update: Public Hearing Scheduled

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug Competition Action Plan (DCAP), FDA finally unveiled its plan for stimulating and improving the marketplace for biosimilars in the U.S. The newly released Biosimilar Action Plan (BAP) is a 9-page, easy-to-read document. As Commissioner Gottlieb indicated in his statement about the release, the BAP is “is aimed at promoting competition and affordability across the market for biologics and biosimilar products.”

As we’ve previously discussed on this blog (see here, here, and here), the Food and Drug Administration under Commissioner Scott Gottlieb has been at the forefront of efforts to “Tackle Drug Competition to Improve Patient Access” – as per a June 27, 2017 FDA press release related to Dr. Gottlieb’s multi-pronged DCAP. In the absence of direct authority over pricing-related issues, as the Commissioner regularly mentions in his public appearances, Dr. Gottlieb and his leadership team nonetheless have demonstrated creativity and commitment towards improving various FDA-related bottlenecks for drugs and biologics – for players in both the innovator and follow-on product environments.  Continue Reading FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” Continue Reading FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was likely welcome news to many politicians from both parties, as well as to President Trump, who has publicly shamed pharmaceutical companies for the high prices of their products but has done little to advance concrete policies in this area.

Dr. Gottlieb has been consistent over the years, including during his recent confirmation process, in his view that FDA should take a more active role in fostering competition and reducing unnecessary regulatory barriers. So it was not surprising when he was selected by Trump to lead the Agency, nor when he received a relatively warm welcome from Senators concerned about the direction prices have been going in recent years. Continue Reading FDA Commissioner Hints at Drug Pricing-Related Initiatives