FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals, de novo classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide “a flexible, patient-centric, benefit-risk approach” that is “tailored to the type and intended use of the device and the type of decision” required. For example, PMA and de novo requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.
Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a draft guidance, titled “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA’s guidance documents from 2001 and 2004.
The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
Read the full text of this Alert on the Duane Morris LLP website.
The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.”
Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States.
FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.
Read the full text of this client Alert, including lists of what to have prepared for meeting requests and the actual meetings, on the Duane Morris LLP website.
With Congress’s recent passage of the 21st Century Cures Act (the “Cures Act”) by an overwhelming majority, and President Obama’s anticipated signing of the bill, we expect that the Cures Act will soon become law. The Cures Act is intended to accelerate development and FDA approval of medical innovations such as cancer treatments, precision medicine and regenerative medicine.
The Cures Act also is designed to provide easier patient access to experimental therapies on a “compassionate use” or “expanded access” basis in response to patient demand for easier access to these therapies before they are FDA-approved. Companies engaged in clinical trials will need to adopt corporate expanded access policies and make them publicly available within the deadlines set by the Cures Act (described below).
If you have any questions about how to develop, implement or manage an expanded access policy or how any other aspect of the Cures Act will impact your company, please contact Vicki Norton, Sandra Stoneman, or any other member of the Duane Morris Life Sciences practice group. Continue reading Alert: Drug and Device Developers Should Be Aware of the Expanded Access Policy Requirement under the 21st Century Cures Act.→
Virtually all life sciences companies use routine protocols which they believe will protect their intellectual property and other confidential or “trade secret” information. Among these routine proactive protocols are having a standard confidentiality/nondisclosure agreement (sometimes referred to below as “NDA”), limiting access to confidential and trade secret information, periodic internal audits of safeguarding methods, and more. But are “trade secrets” the same as “confidential information?” Continue reading “Confidential” vs. “Trade Secret” – A Non-Binary Dilemma→
By Jennifer A. Kearns, John M. Neclerio and Vicki G. Norton
Who doesn’t like the favorite sandwich of childhood – peanut butter and jelly? The two substances blend and meld together, creating a delectable gooey, messy, sticky and sweet treat.
In the life sciences, commingled intellectual property can also create “gooey,” messy and sticky problems for companies. Unfortunately, there’s nothing sweet about commingled IP and the complications that can arise from it, and you can be sure that an experience arising from claims of commingled IP will leave a sour taste in your mouth. Here we discuss proactive or preventative steps that companies can take to reduce the risk of commingling IP.