Rising Drug Costs Continue to be a Concern
During the presidential campaign, Donald Trump highlighted the need to address rising drug costs, stating the drug industry was “getting away with murder.” Several recent high-price drug increases for HIV/AIDS drugs, hepatitis C drugs, and the EpiPen®, among others, have also raised Congressional, state, and public concern about the issue. During the campaign, Trump discussed allowing re-importation of cheaper drugs or allowing the government to negotiate drug prices as ways to lower prices.
The Trump administration has now established a working group, led by the Office of Management and Budget (OMB), which includes top officials from the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), the Health Resources & Services Administration (HRSA), the National Economic Council, and the Office of the Trade Representative, and work has begun on development of an Executive Order on the subject. According to press reports, the Executive Order is expected to include more modest proposals than discussed during the campaign such as speeding up approval of generic drugs as well as proposals that are supported by the drug industry. There is no announced schedule for release of the Executive Order, however, working group members have discussed a July release as well as continued work throughout the summer.
Politico has obtained a copy of a draft Executive Order and is reporting the policy changes provide broad authority for federal agencies including FDA, CMS, the U.S. Trade Representative, and other health agencies to develop measures to deal with drug prices. For example, CMS could design Medicare and Medicaid benefits that would reduce out-of-pocket costs for beneficiaries or modify the Part D protected classes. The Executive Order could also include a focus on value-based drug pricing, which would allow agreements between insurers (including Medicare and Medicaid) and manufacturers that tie payment to drug efficacy. This proposal is supported by the pharmaceutical industry. The order is also expected to roll back a federal 340B drug discount program, which was expanded during the Obama administration, and provides discounts to hospitals and clinics that serve a large number of low-income patients. Not all of these proposals would actually reduce total health system drug prices. In some cases, they would merely shift who is paying. House and Senate Democrats have written a letter to the administration requesting a more comprehensive approach in the Executive Order such as measures to increase transparency in drug pricing and increase price competition.
The FDA has already moved to implement a proposal that is focused on speeding up drug approvals. On June 19, the FDA issued draft guidance for comments which is intended to assist companies in getting shorter reviews of generic drug applications. Initially, this policy will focus on older drugs that have limited competition https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563507.pdf. On June 27, the FDA published a list of off-patent, off-exclusivity branded drugs without approved generics as part of a new policy to speed up generic reviews. Previously, the FDA Commissioner announced the FDA will develop a “drug competition action plan” to facilitate competition among expensive drugs after holding a public hearing on ways to accomplish this goal and will move to clear the backlog of FDA reviews of generic drugs.
Initially, curbing excessive drug prices had bipartisan support in Congress, and Congress started to move on drug prices. However, it appears partisan gridlock over the Affordable Care Act (ACA) repeal and replace legislation will thwart any real congressional action this year. The Senate Health, Education, Labor, and Pension (HELP) Committee held a hearing in early June which focused on patient costs for drugs. The HELP hearing demonstrated a lack of bipartisan consensus on the problem and potential solutions, with Republicans focusing on bringing more drugs to the market faster to promote competition and the Democrats focusing on more active policies like government negotiation of Part D prices. A second HELP hearing scheduled for July has been canceled, and it is unlikely a third hearing planned for the fall will be held. The House Energy and Commerce Committee said they are planning a hearing on the issue, but there is no scheduled date.
States have also moved to address drug prices. In June, Nevada enacted legislation to require increased transparency of drug prices for treatment of diabetes. Companies that have raised a drug’s list price over a certain amount must disclose information about the costs of making and marketing the drug and any rebates provided to Pharmacy Benefit Managers (PBMs). The legislation also includes provisions for more PBM transparency. Vermont already has a drug price transparency statute on the books and has produced a report on egregious drug price spikes. Maryland recently passed legislation that provides authority for the Attorney General to target generic drug makers who increase the acquisition cost of a generic drug more than 50 percent in one year and to impose civil penalties or lower the price, though this has recently been challenged in court.
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