Despite The FDA's Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs.

For decades Black patients have been underrepresented in clinical trials of new treatments. In response, in 2015 the Food and Drug Administration (FDA) launched a five-year action plan aimed at improving diversity in and transparency of pivotal clinical trials for newly approved drugs. The plan contained many action steps that were aimed at improving the racial representativeness of clinical trials and enhancing the reporting of new drug side effects and benefits across diverse populations. Yet, relying on the FDA's Drug Trials Snapshots website, we failed to find evidence that the action plan improved representation of Black trial participants. Black patients remained inadequately represented in clinical trials for drugs, with a median of one-third the enrollment that would be required, whether the trials were started before, during, or after the action plan. Fewer than 20 percent of drugs had data regarding treatment benefits or side effects reported for Black patients; neither measure improved during the action plan period.

Association of Prescription Drug Price Rebates in Medicare Part D With Patient Out-of-Pocket and Federal Spending.

The increasing cost of prescription drugs is a burden for patients and threatens the financial stability of the US health care system. Rebates are a form of price concession paid by a pharmaceutical manufacturer to the health plan sponsor or the pharmacy benefit manager working on the plan's behalf. Proponents argue that rebates result from vigorous negotiations that help lower overall drug costs. Critics argue that rebates have perversely increased the costs patients pay out of pocket, as well as the costs for Medicare as a whole. This special communication discusses how the availability of rebates for drugs covered by the Medicare Part D program may raise costs for patients and Medicare while increasing the profits of Part D plan sponsors and pharmaceutical manufacturers. Two policy alternatives are herein proposed that would reconfigure cost sharing to lower patient out-of-pocket costs and reduce cost shifting to Medicare.