President Biden called for Medicare negotiation “across the board” in a recent speech on his Build Back Better agenda.

Biden’s remarks focused on the burden of high drug costs for patients, particularly Americans with high-cost diseases. Biden called for Congress to only consider the most aggressive version of Medicare negotiation, which would negotiate for all drugs (not just the costliest) and apply to the commercial market. Biden also called for a 95% excise tax on manufacturers that do not negotiate with Medicare and make those prices available to the commercial market, a feature of HR 3 that has not yet been taken up by the Senate. Biden also made brief comments on importation from Canada and inflation rebates to lower drug prices. To watch the full speech, click here.

Vulnerable Democrat Senators filed an amendment that called for Medicare negotiation during the budget process.

Senators. Bennet (D-CO), Cortez Masto (D-NV), Kelly (D-AZ), Warnock (D-GA), and Hassan (D-NH) wrote the amendment that urged Senate to pass many of Biden’s social safety net proposals, including Medicare negotiation. The amendment was not brought up to vote but has solidified their position behind Biden’s policies ahead of their election. To read the full amendment, click here.

The FDA is soliciting guidance on if generic drug applications, submitted before the Hatch-Waxman Act, should be treated as new drug applications (NDA).

This action could allow older generics to be listed as reference drugs for other, new generic products. Bob Pollock, former acting deputy director of FDA’s Office of Generic Drugs, noted that this policy would have a far-reaching impact in the generic drug space. The FDA is requesting comments on if there is any rationale for not treating these drugs as NDAs. To read the full Federal Register notice, click here.

• To read Bob Pollock’s full blog post, click here.  

The US Chamber of Congress and the Pharmaceutical Care Management Association (PCMA) filed separate suits against a Trump administration final rule.

The rule, “Transparency in Coverage,” would increase transparency by requiring health insurers and employers to disclose drug net prices and out-of-pocket costs. The PCMA believes that the rule would inadvertently increase drug prices due to weakened negotiating power with the drug manufacturers. To read the full article, click here.

Merck is requiring contract pharmacy transactions for hospital covered entities to provide claims data to receive 340B discounts.

The large manufacturer previously asked hospitals for their 340B claims data, but the program was optional and hospital participation was low. Novartis and Sanofi also request hospitals to share 340B claims data, but their programs are both on a voluntary basis. To read the full press release, click here.

Researchers at Johns Hopkins Bloomberg School of Public Health published an analysis of manufacturer drug coupon utilization in JAMA.

The researchers examined common factors associated with manufacturer drug coupon usage, such as patient cost, drug, and drug-class characteristics. They concluded that coupon use was significantly associated with high mean per-patient costs but not patient out-of-pocket costs. To read the full study, click here.

CIDSA Experts in the News

Sean Dickson, alongside researchers from Bentley University, analyzed the impact that lowering drug prices would have on pharmaceutical innovation. Researchers examined the relationship between revenue and R&D expenses for drug companies of varying sizes from 2000-2018. The study found that for large drug manufacturers, changes in revenue was positively associated with corresponding changes to R&D expenditures; small manufacturers had no association between revenue and R&D spending. The pharmaceutical industry often argues that high drug prices are necessary due to the high costs of developing innovative drugs, but researchers concluded that this is not true and that policymakers should not be led to believe they must choose between ensuring affordability and pharmaceutical innovation. To review the full study, click here.  

Stacie Dusetzina spoke with reporters at AP on how hospital groups, startups, and nonprofits have begun making their own drugs to combat high prices. Dusetzina spoke on how these groups are coming up with novel solutions to the causes of high drug prices and that these solutions could increase competition among some costly drugs. To read the full article, click here.