FDA Regulatory

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as part of the Coronavirus Aid, Relief, and Economic Security Act that was signed on March 27, 2020 (see our prior posts here and here).

As we’ve reported previously, at the end of 2020, the Office of Non-Prescription Drugs (ONP) of the Food and Drug Administration (FDA), launched a webpage for its brand new user Over-The-Counter Monograph User Fee Program (OMUFA) – available here – published programmatic fee rates for Fiscal 2021 (which ended on September 30, 2021), and subsequently posted a public arrears list of facilities that did not make their FY2021 facility payments as was required to be done by May 10, 2021. Drugs produced by those in-arrears facilities are considered misbranded under the law.

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical laboratory testing in general during the COVID-19 public health emergency. We highlighted at the time an August 2020 Trump Administration order barring FDA from requiring premarket review for any LDT unless the agency goes through formal rulemaking procedures. We also speculated that although “the regulatory framework and policies surrounding LDTs will be a prominent topic of debate in 2021…there will be no quick resolution of these issues, either at a legislative or agency policy level, in the short term and that LDTs will likely remain in a gray area of FDA regulation and policy for the foreseeable future.”

In this fireside discussion, Mintz attorney Joanne Hawana and Aaron Josephson and Anthony DeMaio from ML Strategies explored policy activities that will likely have the greatest impact on stakeholders in 2021, and how the new Administration may impact the FDA in the year ahead and beyond.

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

Despite the COVID-19 pandemic, the House Energy & Commerce Committee continues work on several health policy issues, including Orphan Drug Act reform and continuous manufacturing.

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph drugs. We previously blogged about the surprise addition of the OTC monograph reforms within the CARES Act. On May 29, 2020, the Office of Nonprescription Drugs within the Food and Drug Administration (FDA) held a webinar titled “Monograph Reform is Here!” (a recording of the webinar is available here), which included key highlights from the OTC monograph reform.

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020.  The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously. 

Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight some changes made to the programs when they were last reauthorized through the 2017 Food and Drug Administration Reauthorization Act (FDARA) (P.L. 115-52) and consider what could be included in the upcoming user fee reauthorization package.

A history of FDA human medical product user fee programs, including those for prescription drugs (PDUFA), generic drugs (GDUFA), biosimilars (BsUFA), and medical devices (MDUFA), their negotiation and reauthorization, and how manufacturers and patients can participate and get involved in the negotiations.