CAPA Submits Comments to FDA On Collaborative Efforts With FTC To Increase Competition

By Matthew Lane, Executive Director of the Coalition Against Patent Abuse (CAPA)

On March 9, 2020, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) held a public workshop to discuss their collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and deter anticompetitive behaviors in the biologic marketplace. The Coalition Against Patent Abuse (CAPA) recently submitted comments to the FDA on this joint initiative with the FTC to increase biosimilar competition. CAPA is encouraged by this partnership to develop policies that will increase competition generally and is hopeful that the agencies will assist Congress in developing pro-competitive drug policies where necessary. 

In order to drive affordability for American patients, the marketplace for prescription drugs must be open to competition. In many cases, however, biologic pharmaceutical companies create barriers to entry for biosimilars which drives out-of-pocket costs up for millions of Americans.  

In December 2019, the FDA updated their study on generic drug competition and prices that makes a clear the link between the number of generic competitors and the availability of dramatically lower prices for patients at the pharmacy counter. This study showed that prices dropped by seventy-nine percent on average when four generic companies enter the marketplace, and by over ninety-five percent on average when six or more companies were able to compete. The same competition should substantially benefit the biosimilars market. 

Fortunately, both the FDA and FTC have tools to promote competition and they are both uniquely positioned to advance sound drug pricing policy through conducting fact finding and offering reports, testimony, and other guidance to policymakers currently working on such policy. The FTC not only has an enforcement mandate, but also a policy mandate to conduct studies, conduct workshops, offer Congressional testimony, and write reports.

Transparency is also important for a healthy market and helps promote competition. It is important for generic manufacturers, and the public, to understand basic facts about biologics including the scope of claimed exclusivities for biosimilars. Accurate patent information is essential for competition enhancing transparency in the biologic market. To that end, we applaud the FDA for its efforts to update the Purple Book to an online accessible searchable database and recommend that the FTC and FDA work with Congress to assist them in passing legislation that will enable the FTC to include this patent information, and bring the Purple Book fully in line with the Orange Book.

Further, the FDA has engaged in a number of regulatory initiatives to increase safety and public participation in the drug approval process. However, these same initiatives can be abused for anticompetitive ends. To prevent abuse, we encourage the FDA and FTC to continue working together to advise Congress when these anticompetitive abuses are occurring and to make recommendations on methods to fix legislation to close any loopholes open to abuse. This is not only important for existing legislation, but also for future legislation currently being contemplated to address drug prices and other drug related issues.

Overall, we applaud the FTC and FDA on their progress towards increasing competition to bring affordability into the marketplace for millions of American patients.

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