YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

In its March 20 guidance, FDA addresses postmarket adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. Kathleen Sanzo, Jacqueline Berman, Michele Buenafe, and Dennis Gucciardo explain the guidance in this LawFlash.

Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites. These relaxed requirements will allow patients continued access to their medications during social distancing. Rebecca Dandeker and Jacqueline Berman dissect the new policy in their recently authored LawFlash.

Read the LawFlash.

The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve. This announcement follows a March 10 guidance that routine foreign inspections were suspended. For-cause inspections will proceed if deemed “mission-critical.” Dennis Gucciardo, Michele Buenafe, and Jaqueline Berman address the tools that FDA will use to oversee the safety and quality of FDA-regulated products during this emergency in their recently authored LawFlash.

Read the full LawFlash.

In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.

The guidance aims to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity.”

Partners Kathleen Sanzo and Jacqueline Berman provide key takeaways from the guidance in this LawFlash.

The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs. The guidance comes in response to hand sanitizer shortages during the coronavirus (COVID-19) emergency, particularly among employers in the healthcare and essential services sectors where employees are still present or interacting with consumers. Morgan Lewis lawyers Kathleen Sanzo and Jacqueline Berman authored a lawflash detailing issues for manufacturers and purchasers under the new policy.

Read the full LawFlash

FDA issued a draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products (Draft Guidance), on December 19, 2019, as an expansion of its 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998 Guidance). The 1998 Guidance provided examples of evidence that FDA could consider to be confirmatory evidence to potentially support FDA approval of a marketing application based on one adequate and well-controlled clinical trial. The new Draft Guidance provides further detail on clinical trial design considerations, as well as forms of confirmatory evidence that sponsors may consider when proposing to rely on a single adequate and well-controlled clinical trial.

The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List of Approved Drug Products with Therapeutic Equivalence Evaluation (referred to as the Orange Book). Historically, FDA’s Orange Book role has been solely ministerial. However, over the next year, FDA may begin taking a more active approach to the Orange Book.

In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019. As expected, parts of CDER were affected by the government shutdown, which has caused a delay in the development of some of the Center’s policy activities and accomplishments to start the year. However, despite the delay, Dr. Woodcock provided updates on several initiatives coming up in 2019. Below is a summary of the major initiatives to expect in 2019. Overall, it looks like CDER is gearing up for a busy and productive year. Industry stakeholders should be on the lookout for many new developments coming out of the Center.

After several delays, the revised US Federal Policy for the Protection of Human Subjects (also known as the Common Rule) went into effect on January 21. The Common Rule is generally applicable to research conducted or supported by one of the federal departments or agencies that has integrated the rule into its own regulations (e.g., US Department of Health and Human Services (including the National Institutes of Health), US Department of Agriculture, US Department of Defense). Some clinical trial sites may also apply the Common Rule across all clinical research projects, regardless of funding source, through a US Office for Human Research Protections Federal Wide Assurance.

Despite the mandate under the 21st Century Cures Act to harmonize FDA regulations with the Common Rule to the extent practicable and allowable under existing legislative provisions, FDA has yet to propose aligning regulations. Rather, FDA issued guidance titled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations. As of right now, while FDA is aware of new inconsistencies between its human subject regulations and the revised Common Rule, the agency has advised that when a given study is subject to both sets of regulations, the rule that offers greater human subject protection should be applied. The guidance sets forth FDA’s position on the following areas of potential discrepancies between the Common Rule and FDA regulations:

Update: FDA has now extended the comment period for this proposed rule to February 13, 2019.

FDA recently announced a proposal to add an exception to the agency’s informed consent requirements. Under the proposed rule, FDA will allow Institutional Review Boards (IRBs) to waive or alter informed consent for clinical trials that present only minimal risk to the subjects. This proposal is similar to the policy set forth in FDA’s guidance document on the same topic, which we have written on previously.