The accelerated approval pathway allows the FDA to approve drugs to be marketed that have not yet shown sufficient clinical benefit but are expected to fill an unmet need. This probe is in response to significant public remarks on the seemingly rushed approval of aducanumab. In addition to the review of the approval of Aduhelm itself, the OIG will investigate how the FDA uses the accelerated approval pathway in general. To read the work plan, click here.
The rule was intended to lower drug costs in Part B by setting the Medicare reimbursement rate to the lowest price in other developed nations. The November 2020 rule was supposed to go into effect on January 1, 2021, but due to multiple lawsuits and stays, there has been a nationwide preliminary injunction in effect until August 9, 2021. Most recently, CMS has proposed to withdraw the MFN rule completely and is requesting comments. To read the full notice, click here.
Most notably the score includes an estimated $50.8 billion in savings from delaying the Trump administration rebate rule. The rebate rule had previously been scored to cost $180 billion; Congress is still considering using the remaining savings from withdrawing the rule altogether as a pay-for towards the reconciliation bill. To review the full score, click here.
The FTC has made prohibiting pay-for-delay abuses one of their priorities since the Actavis v. FTC case in 2013, but no longer has the authority to require companies to pay back any profits they made from the anticompetitive tactics. The lawsuit from 2018 alleged that AbbVie and Besins made an additional $448 million in profits due to pay-for-delays deals that should be given back to consumers. To read the full press release, click here.
Skinny labeling is often used by generic manufacturers and allows them to market generics for one specific use even though it could have another indication that still has a patented, brand drug. Skinny labels increase generic accessibility and lowers costs for patients, but this ruling could “make it harder for generics and biosimilar manufacturers, in good faith, to carve out infringing uses of their products from their product labels,” according to Columbia University associate clinical professor of law, Christopher Morten. To read the full article, click here.
Rachel Sachs and Mariana Socal will be on an expert panel in an upcoming public webinar hosted by the University of Pennsylvania Leonard Davis Institute of Health Economics on September 17 from 12 – 1pm ET. The webinar, Drug Pricing: Policy and Politics, will focus on current policy options and the roles of the federal government and markets. To register for the event, click here.
Ameet Sarpatwari coauthored an analysis of barriers to biosimilar market growth in the most recent Health Affairs journal. Sarpatwari and colleagues examined why there has been limited competition since the passage of the Biologics Price Competition and Innovation Act (BPCIA) and found two key issues. After analyzing litigation in this space, they found that noncompliance with the litigation process outlined in BPCIA and the sheer number of patents on original biologics are preventing effective competition in biologic markets. To read the full analysis, click here.