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.

As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.

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.

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.

Some areas that companies should consider include the following:

  • Supply chain disruption, including active pharmaceutical ingredient (API) and excipient shortages
  • Drug shortages and related FDA notices
  • FDA inspection priority shifts
  • Potential impacts on import surveillance
  • Delays in FDA’s review of pending drug applications
  • Possible impacts on clinical trials and necessary changes to relevant trial documents
  • The impact on drug promotion and new risks created by the changing landscape

For further analysis, please see our March 13 LawFlash, Potential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech Industries.

The US Nuclear Regulatory Commission (NRC) and state agencies oversee the possession and use of radiopharmaceuticals and medical devices containing radioisotopes. In this regard, the NRC recently issued two information notices in response to medical events arising from the administration of radiopharmaceuticals.

The first, Information Notice 2019-11, alerts medical-use licensees to four strontium (Sr)-82/rubidium (Rb)-82 generator elution events that resulted in patients receiving concentrations of Sr-82 and Sr-85 in excess of regulatory requirements. The IN describes four separate events in which approximately 90 patients were administered Rb-82 chloride for cardiac imaging that contained Sr-82 and Sr-85 concentrations in excess of the regulatory limits identified in 10 CFR § 35.204.

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.

As part of the US Food and Drug Administration’s (FDA’s) overall reorganization of the Office of New Drugs, the former Office of Hematology and Oncology Products (OHOP), the FDA office responsible for approving cancer therapies, was recently restructured and renamed the Office of Oncologic Diseases (OOD).

Per Dr. Richard Pazdur, the acting OOD director, the reorganization will allow for greater stakeholder engagement and streamline the drug review process. OOD is now composed of six divisions, including three divisions of oncology.

US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products. The bill, previously known as the CREATES Act (H.R. 965/S. 340), allows developers of 505(b)(2) New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products, as well as biosimilar products, to sue companies holding NDAs or Biological License Applications (BLAs) (each, a License Holder) that refuse to provide “sufficient quantities” of an approved reference drug or biologic on “commercially reasonable, market-based terms.” “Sufficient quantities” are those the developer determines it needs to conduct testing and other regulatory requirements to support an application. “Commercially reasonable, market-based terms” are defined as (1) the nondiscriminatory price at or below the most recent wholesale acquisition cost (WAC) for the product, (2) a delivery schedule that meets the statutorily defined timetable, and (3) no additional conditions on the sale.

FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)-related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of saleable returned product prior to further distribution until November 27, 2020. FDA’s decision was necessary because existing drug distribution systems are not prepared to handle and verify the large volumes of returned product in the supply chain in the United States. The extended compliance period also allows wholesalers to issue transaction statements for returned product without certification statements concerning verification processes.

Now is the time for pharmaceutical manufacturers to review their Open Payments/Sunshine Act internal compliance procedures, data collection forms and databases, and reporting and recordkeeping templates for payments and transfers of value made to healthcare providers. On August 14, 2019, the Centers for Medicare and Medicaid Services (CMS) published a Proposed Rule seeking to expand the Open Payments program, including the number and types of covered recipients and payment categories. As a result, drug manufacturers have at least two reasons to quickly conduct a comprehensive internal examination of their Open Payments program.