September 25, 2020
Last week the president issued an executive order, which aims to reduce drug prices by tying them to prices in other countries. The executive order was drafted in July but was withheld to give drug manufacturers an opportunity to create another option. After negotiations fell apart, the president released the order to the public.
The order says the U.S. would pay the “most favored price” for a drug, or the lowest price paid by any country in the Organization for Economic Cooperation and Development (OECD), a 37-member international organization dedicated to stimulating trade around the world.
President Trump said, “Americans pay more per capita for prescription drugs than residents of any other developed country in the world. It is unacceptable that Americans pay more for the exact same drugs, often made in the exact same places. Other countries’ governments regulate drug prices by negotiating with drug manufacturers to secure bargain prices, leaving Americans to make up the difference.”
The order directs the Department of Health and Human Services (HHS) to run a trial period to determine how the “most favored nation” pricing would impact reimbursement and spending in Medicare Part B, which covers physician-administered medications (like IV chemotherapy), and Medicare Part D, which covers prescription drugs. The Centers for Medicare and Medicaid Services (CMS) has been charged with implementing the trial period, but the timing is unclear. Guidance will be released in the coming weeks that will provide additional details. We will provide updates as they occur.
On Tuesday, the House passed a short-term spending deal (also known as a continuing resolution) by a vote of 359-57. The bipartisan bill will fund the government through December 11, avoiding a large-scale government shutdown before the upcoming election in November. The bill will now move to the Senate. To keep the government open, the bill must pass the Senate and be signed by the president by September 30, the last day of the fiscal year.
The deal was on the verge of collapse last week as Republicans looked to provide extra funding to the farm bailout program, which supports farmers impacted by trade tariffs placed on China by the president. In exchange for the bailout funding, House Democrats secured $8 billion in funding for nutrition programs for children impacted by the ongoing pandemic.
Senate Majority Leader Mitch McConnell has yet to comment on the bill, but it is expected to pass the Senate and be sent to the president for signature. Amid ongoing work to fill the Supreme Court vacancy left after the death of Justice Ruth Bader Ginsburg, neither party wants to risk a government shutdown.
This is a developing story, and we will provide updates as they occur.
The Food and Drug Administration (FDA) is expected to release guidance for emergency use of potential COVID-19 vaccines, when they become available. The guidance must be approved by the White House before it is released to the public, which could be as early as next week.
If approved, the guidance would detail the data needed from clinical trials to warrant clearance from the FDA. The new standards would be more stringent than standards for previous stages of the trials, as the next phase of COVID-19 vaccine trials is the limited release of the vaccine(s) to the broader public. The FDA recommends any data submitted be vetted by an independent team of experts before it is sent to the agency.
The FDA told Pfizer and Moderna, the two companies with active phase 3 trials, that subjects in their trials need to be monitored for possible side effects for at least two months before the vaccines will be considered for approval.
As we await a vaccine, please continue to protect yourself and others by following guidelines from the Centers for Disease Control and Prevention (CDC). This is a developing story, and we will provide updates as they occur.