Other FDA Developments

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On September 15, 2023, FDA published an update to the guidance document – “Breakthrough Devices Program, Guidance for Industry and Food and Drug Administration Staff.” Notably, FDA states that it may consider a medical device’s ability to improve health and healthcare disparities when deciding whether to designate a medical device as a breakthrough device. The agency may use this information to determine whether a candidate device provides more effective treatment or diagnosis when compared to the current standard of care. Below, we provide additional information regarding the breakthrough device program and the updated guidance.…

Continue Reading FDA Updates Breakthrough Device Guidance

On August 1, 2023, the U.S. Food & Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”) issued a joint letter to all Americans to provide a status update regarding the ongoing shortage of prescription stimulants. Stimulants fall under the purview of both FDA and DEA because they are controlled substance drugs. Both agencies recognize the important role of prescription stimulants when it comes to the treatment of conditions such as attention-deficit/hyperactivity disorder (“ADHD”), binge eating disorder, and narcolepsy.

According to the letter, the agencies are working closely with manufacturers and other members of the drug supply chain to address these shortages, which are the result of two main factors—manufacturing delays and an increased demand for the stimulants.…

Continue Reading FDA and DEA seek to ameliorate the shortage and misuse of stimulants

On April 7, 2023, only minutes apart, two federal district courts issued rulings on cases challenging the Food and Drug Administration’s regulations governing mifepristone, a key medication for women seeking an abortion. Both rulings faulted the FDA’s handling of the approval and its subsequent restrictions on the dispensing of mifepristone, but the two rulings came to very different conclusions as to what the availability of the drug should be.

Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas issued a 67-page opinion ordering that the FDA’s initial approval of the drug, which was approved in 2000, should be stayed pending the court’s full review of the merits of the case. The court then stayed its own order for seven days to allow the FDA to appeal to the U.S. Court of Appeals for the Fifth Circuit.

Just minutes later, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington issued a 31-page opinion ordering FDA and HHS not to make any changes to the availability of mifepristone under the current operative Risk Evaluation and Mitigation Strategy (REMS) program, which requires the drug to be prescribed and dispensed only by certified providers, among other requirements. Unlike Judge Kacsmaryk, whose injunction has nationwide effect, Judge Rice limited the effect of his order to only the 17 states and the District of Columbia who brought the challenge in his court. The 17 plaintiff states in this lawsuit are: Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington and the District of Columbia.

The most difficult-to-reconcile aspect of the two orders is the fact that Judge Kacsmaryk’s order is a nationwide stay of the drug’s approval, while Judge Rice’s order to maintain the status quo availability only applies to the specific plaintiffs.  Notably absent from the Washington order’s applicability would be California, Massachusetts, New Jersey, New York, North Carolina, New Hampshire, and Virginia.…

Continue Reading Mifepristone Cases – Our Thoughts

On September 27, 2022, FDA announced the publication of a  final guidance  document entitled Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff (Final CDS Guidance), which focuses on clarifying the types of clinical decision support (CDS) software functions that are excluded from the definition of device by the criteria in section 520(o)(1)(E) of the Federal Food Drug and Cosmetic Act.

This final guidance document addresses industry comments made in response to FDA’s September 2019 draft guidance (Draft CDS Guidance). The Final CDS Guidance streamlines the Draft CDS Guidance by focusing the scope on CDS intended to be used by state licensed, registered, or certified health care professionals , rather than those also used by patients and caregivers, which were included in the scope of the Draft CDS Guidance.…

Continue Reading FDA Announces Final Guidance on Clinical Decision Support Software

On May 10, 2022, FDA published draft guidance entitled, “Benefit-Risk Considerations for Product Quality Assessments”, which describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA’s review as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to such applications.

In the draft guidance, FDA reiterates its risk-based regulatory approach and applies it in the product quality assessment context.  Specifically, the draft guidance states that FDA continues to identify potential risks to product quality associated with the formulation, manufacturing process, and packaging components when conducting a product quality assessment as well as the proposed control strategy for mitigating those risks.…

Continue Reading FDA issues draft guidance for use in product quality assessments

A substantial shift for genetically engineered (“GE”) food regulation may be on the horizon thanks to a USDA proposed rule with a fast closing comment period, which ends on February 26, 2021. The proposed rule strips FDA’s jurisdiction over food-bearing GE livestock and places it within USDA’s purview, thereby granting USDA jurisdiction over pre-market review…

The Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) have been fighting fraudulent and deceptive advertising of health care devices, household cleaners, nutrition supplements, and other health care products promising to protect or mitigate the effects of the virus for pandemic-wary consumers since March 2020. Despite these efforts, false and misleading…

On October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFR) in an effort to ensure that participants in CMS programs have no-cost access to any forthcoming Food and Drug Administration (FDA or Agency) authorized or approved COVID-19 vaccine.

The IFR governs any vaccine that…

On August 31, 2020, the Food and Drug Administration (FDA) issued draft guidance regarding principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation.[1]  Patient-reported outcome (PRO) instruments facilitate the systematic collection of how patients feel and function during a clinical trial.  FDA recognizes this information as important…

On June 17, the Food and Drug Administration (FDA) continued its efforts to mitigate COVID-19’s disrupting impact on clinical trials by issuing guidance on statistical considerations for changes to trial conduct (FDA previously relaxed restrictions on protocol modifications). As expected, public health measures designed to control COVID-19’s rapid emergence as a global pandemic—social distancing, travel…

The Food and Drug Administration (FDA) recently released new draft guidance documents to clarify its approach to regulating software as a medical device. The first draft guidance, Clinical and Patient Decision Support Software, addresses provision of the 21st Century Cures Act that exempts certain clinical decision support software from the definition of a medical device. …

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of…

On November 9 and 10, 2016, the Food and Drug Administration (FDA) is hosting a public hearing on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” The hearing is intended to inform FDA’s “comprehensive review of its regulations and policies” pertaining to such communications. The FDA poses a number of specific questions to stakeholders, covering such topics as:…
Continue Reading FDA to Host Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Medical Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.

What is a biosimilar product?

Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. Notwithstanding minor differences in clinically inactive components, there can be no clinically meaningful differences between the biological product and the reference product in terms of the safety and efficacy.  In 2010, the Biologics Price Competition and Innovation Act (“BPCIA”) was enacted as part of the Affordable Care Act in order to provide an abbreviated licensure pathway for a biosimilar that partly relies on the data originally submitted to the FDA by the reference product sponsor for approval.
Continue Reading FDA Issues Draft Guidance on Labeling For Biosimilar Products

On January 22, 2016, the federal Food and Drug Administration (“FDA”) issued a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks.  The draft guidance details the agency’s specific recommendations, which address monitoring, identifying and managing cybersecurity vulnerabilities in medical devices that are software, or contain software (including firmware) or programmable logic once they have entered the market. The draft guidance represents a part of the agency’s ongoing efforts to ensure the safety and effectiveness of medical devices in the face of potential cyber threats at all stages in their lifecycles.  Specifically, the draft guidance follows multiple public workshops on the issue and previous FDA guidance titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” which contains premarket recommendations for managing cybersecurity risks during the design stage of device development.  We previously blogged about this here. …
Continue Reading FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices

As discussed on our sister Life Sciences Legal Update blog, the FDA is holding a public two-day workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” on January 20-21, 2016. The FDA seeks to bring together diverse stakeholders to highlight past collaborative efforts, identify tools to aid stakeholders in implementing disclosure…

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.…

As discussed on our Life Sciences Legal Update blog, the FDA has released draft guidance clarifying its acceptance of medical device clinical data from studies conducted outside of the United States. The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations…