Right to Try, Opioids, and Drug Prices Featured in State of the Union

During his State of the Union address last week, President Trump discussed several healthcare-related issues. The President endorsed right-to-try legislation, stating that terminally ill patients should have immediate access to experimental treatments that have not yet completed the approval process. Such legislation passed the Senate unanimously last year and awaits action in the House. The President reiterated his commitment to fighting the opioid epidemic by increasing treatment for those struggling with addiction and immigration reform. Finally, President Trump stated that he has directed his Administration to make the issue of high drug prices one of its top priorities. Rep. Joe Kennedy (D-Mass.) delivered the Democrat’s response to the speech, calling for increased resources for Medicaid and the Affordable Care Act (ACA) and urging support for a health care system that “offers mercy.”

CDC Director Resigns

Director of the Centers for Disease Control and Prevention (CDC) Brenda Fitzgerald, MD has resigned amid a scandal involving her stock holdings. The announcement closely followed a Politico report that Fitzgerald bought shares in tobacco, food, and drug companies while serving as CDC director. The U.S. Department of Health and Human Services (HHS) stated that such financial interests “imposed a broad recusal limiting her ability to complete all of her duties as the CDC Director,” and that she was unable to divest from them in a definitive period of time. Dr. Anne Schuchat, Principal Deputy Director of CDC, has been tapped to lead the agency as Acting Director.

CDC to Cut Spending on Global Epidemic Prevention Efforts

According to a report from the Washington Post, the Centers for Disease Control and Prevention (CDC) plans to significantly cut global epidemic prevention efforts. A five-year emergency package approved in 2014 to respond to the Ebola epidemic expires in September 2019, and the agency has cautioned its staff not to expect any new resources for the global health security programs. The CDC plans to cut activities in thirty-nine out of forty-nine countries and narrow its focus to the following ten priority countries: India, Thailand, Vietnam, Jordan, Kenya, Uganda, Liberia, Nigeria, Senegal, and Guatemala.

Bipartisan Lawmakers Inquire on Status of Product Shortages

Sens. Marco Rubio (R-Fla.) and Richard Blumenthal (D-Conn.) have written to Commissioner of Food and Drugs Scott Gottlieb regarding the shortage of intravenous fluid bags and other medical products resulting from the effects of Hurricane Maria in Puerto Rico last year. The lawmakers ask when the products will become widely available, whether approval of new suppliers is temporary or permanent, and what Congress can do to assist with the situation. On Thursday, the Food and Drug Administration (FDA) provided an update on the shortage, noting that this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products. Most recently, the FDA was able to extend the expiration dates of certain products, including some 500 ml size saline bags, after carefully examining the data submitted by the company to ensure that it meets the FDA’s quality and safety standards. The FDA will continue to encourage companies to submit data to extend expiration dates for drugs in shortage. The FDA has also been working with manufacturers, such as Baxter and B. Braun, to import products into the U.S. from their foreign facilities, including most recently additional products from a Baxter facility in Brazil.

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