GAO Releases Report on Generic Complex Drugs

The Government Accountability Office (GAO) recently released a report recommending that the Food and Drug Administration (FDA) update the public about the agency’s plans to issue and revise guidance on non-biological complex drugs. The GAO recognized the steps taken by the FDA to address the unique challenges of generic non-biologic complex drug approval, but encourages the agency to announce its plans to issue and revise product-specific guidance for drugs that are non-biological and complex. The U.S. Department of Health and Human Services (HHS) concurred with the recommendations contained within the report. The report was also praised by House Energy and Commerce Health Subcommittee Chairman Michael Burgess (R-Texas) and Ranking Member Gene Green (D-Texas).

Senate Committees Advance HHS Nominees

The Senate Finance Committee has advanced the nomination of Alex Azar to serve as Secretary of the U.S. Department of Health and Human Services (HHS). Republicans on the Committee were united in support of the nomination, with Sen. Tom Carper (D-Del.) being the only Democrat unopposed in the 15-12 roll call vote. Democratic opposition to the nomination largely stems from Azar’s former ties to the pharmaceutical industry and doubts that he can lead the effort to lower the nation’s rising drug prices. While a full Senate floor vote has not yet been scheduled, lawmakers hope to confirm Azar by the end of the month.

The Senate Health, Education, Labor, and Pensions (HELP) Committee advanced the nomination of Brett Giroir to be Assistant Secretary of Health. The nomination was approved by voice vote, despite objections by Democrats on the Committee. Ranking Member Patty Murray (D-Wash.) and her colleagues have expressed concerns about the nominee’s ability oversee the Department’s programs on women’s health in light of the current administration’s ideological position on issues such as family planning and teen pregnancy. Giroir’s nomination now awaits action by the full Senate.

IRS to Provide Medical Device Tax Relief

The Internal Revenue Service (IRS) announced that it would provide companies with nine months of relief from penalties resulting from a failure to pay the medical device tax. The 2.3 percent tax on medical devices created by the Affordable Care Act (ACA) was suspended in 2016 and 2017. The first installment of the tax is due on January 29, but the IRS announced that it won’t apply penalties for failure to make the deposit during the first three quarters of 2018, due to the short time frame between the end of the moratorium period and the due date of the first deposit.

E&C Subcommittee Advances Three Health Bills

The House Energy and Commerce Health Subcommittee advanced three bills last week relating to public health and medical professionals. The Good Samaritan Health Professionals Act (H.R. 1876), which would shield health care professionals from liability when they volunteer during a federally declared disaster, was passed by voice vote and now awaits full Committee action.

The Pharmaceutical Information Exchange (PIE) Act (H.R. 2026) would clarify how drug and device companies can share information as it relates to an investigational use of a drug or device. The bill was reported to the full Committee by a vote of 18-14. Republican committee members argued that the bill would help ensure faster access to new treatments and cures, but many Democrats on the subcommittee expressed concerns about the legislation’s potential to compromise patient safety.

The Subcommittee also considered a discussion draft of the Over-the-Counter (OTC) Monograph Safety, Innovation, and Reform Act. The bill would modernize the Food and Drug Administration’s (FDA) OTC monograph framework and establish a user fee program for regulation of such OTC consumer health products. The Committee print was agreed to by voice vote and now awaits full Committee action.

Opioid Emergency Declaration Extended

Acting Secretary of the U.S. Department of Health and Human Services (HHS) Eric Hargan has signed a 90-day extension of the Administration’s previous declaration of the opioid misuse and abuse crisis as a public health emergency. The renewal is effective January 24.

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