News & Views: 3/22 - 3/28

March 29, 2022

The FDA announced their $8.4 billion budget proposal as part of President Biden’s $5.8 trillion FY23 budget.

The FDA’s request included $3.7 billion in discretionary funding, which would be approximately 11% over fiscal 2022 levels. The budget is intended to cover new efforts, including large allocations towards future pandemic preparedness, as well fund core operations. Notably, $60 million of the budget is allocated towards advancing access to safe and effective medical products. To read the full press release, click here.

HHS announced their plan to study if a disclaimer on direct-to-consumer (DTC) websites of drugs approved through the accelerated approval pathway will help consumers make informed decisions.

As part of their plan, HHS conducted a preliminary analysis of DTC websites of drugs that had been approved through the accelerated approval pathway and found that 27% did not include any sort of disclosure about the product’s accelerated approval. The plan is to conduct two studies, the first on basic comprehension of various wording between oncology groups and the general population and the other, which will exclude oncology groups, will test four consumer-friendly disclosures. To read the full notice, click here.  

A group of eight consumer advocacy organizations joined together to petition HHS to use their march-in rights to lower prices of six drugs.

The letter to Secretary Becerra highlights the burden of high drug costs, particularly on minority communities. The petition focuses on six drugs, including Xtandi, Paxlovid, Epclusa, Descovy, Symbicort, and insulin, but notes that these six are just a starting point. In the event that drug pricing reform is unable to pass Congress, the advocates advise the administration to use their march-in rights on these inaccessible drugs in addition to executive actions to work towards greater health equity. To read the full letter, click here.

Johnson & Johnson announced their decision to restrict 340B discounts for safety-net hospitals.

According to 340B Health, J&J, the world’s largest drug company, is the 16th drug manufacturer to limit their participation in the 340B program. Their new policy will go into effect on May 2 of this year, at which time they will restrict 340B discount pricing at community pharmacies for 29 of their best-selling drugs. To read more, click here.

CIDSA Experts in the News

Sean Dickson spoke with reporters at Inside Health Policy about changes to Medicare Part B reimbursements for Aduhelm. Biogen’s price cut of Aduhelm resulted in prescribing providers receiving a windfall of reimbursements in Q1 of 2022, as the reimbursement was still based on the initial $56,000 price. CMS will adjust Aduhelm reimbursements for Q2 to be based off of the widely available market price (WAMP) rather than the ASP plus 6%. Dickson explains that while providers may be slightly under-reimbursed in Q2 due to this change, those are the same providers who received “windfall reimbursement in Q1.” To read more, click here.

Rachel Sachs spoke with reporters at Axios on proposed reforms to the accelerated approval pathway in response to the Aduhelm approval. Sachs explained that proposed reforms to increase the FDA’s authority and timeliness in removing drugs that fail to complete confirmatory trials will not impact most companies, as most drugs do get full approval within five years. However, companies are pushing back as they are “opposed to any efforts to constrain their ability to get these drugs to market and to sell them,” according to Sachs. To read the full article, click here.

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