What We’re Reading: Plan B Use Plunges; Lower Drug Costs; Clinical Trial Diversity Guidance

States That Enacted Abortion Bans See Drop in Plan B Use

A study published yesterday in JAMA Network Open found that the use of Plan B, a prescription emergency contraception, fell by 60% in states that implemented near-total abortion bans after Roe v. Wade was overturned in June 2022, according to Bloomberg. The study, which examined contraceptive prescriptions in states with moderate to restrictive abortion bans from March 2021 to October 2023, determined that the drop was partly due to clinic closures and misinformation. More specifically, over a dozen states banned abortion after the Supreme Court’s decision, resulting in numerous family planning clinics closing. The researchers determined this as one of the biggest reasons for the decline in Plan B use, along with misinformation about the legality of emergency contraception; this adds to concerns about abortion bans limiting reproductive care. Conversely, Plan B use held steady in states with moderate abortion restrictions.

Biden Administration to Lower Costs of 64 Drugs Through Drugmaker Inflation Penalties

The Biden administration announced yesterday that it will impose inflation penalties on 64 prescription drugs in the third quarter of 2024, lowering costs for certain older Medicare patients, according to NBC News. This is because a provision of the Inflation Reduction Act (IRA) requires drugmakers to pay rebates to Medicare if they raise the price of a medication faster than the inflation rate; this is separate from another IRA provision that allows Medicare to negotiate drug prices with manufacturers. From July 1 to September 30, some patients will pay a lower coinsurance rate for the 64 drugs named in the announcement that are covered under Medicare Part B since each drug company raised the prices faster than the inflation rate. The Biden administration noted that some Medicare Part B patients may save up to $4593 per day during the quarter.

FDA Issues Draft Guidance for Enrolling More People of Color in Clinical Trials

The FDA recently released draft guidance to ensure that drug companies and medical device makers enroll more women and people of color in clinical trials, according to Stat. Although it was released 6 months late, this guidance is the first step in carrying out a law Congress passed in 2022 to help fix the lack of diversity in clinical research. Under this law, Congress requires companies to give the FDA their plans for enrolling patients considered representative of those who would take the respective product. The draft guidance describes the content and format of diversity action plans, along with the timing and process for submitting them; these are required for large phase 3 trials. Companies are encouraged to include their enrollment goals, rationale, and their plan for meeting these goals. The public has 3 months to give feedback on the draft, after which the FDA will start writing the final version.