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

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

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.

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.

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may need to post certain study results for 10 years’ worth of clinical trials (2007–2017), which the US Department of Health and Human Services (HHS) had previously excluded from the requirement.

By way of background, the 2007 FDA Amendments Act (FDAAA) required that HHS include certain study results, referred to as basic results, for approved drugs and biologics on ClinicalTrials.gov. Clinical study sponsors and investigators were required to submit these study results within one year of the estimated or actual study completion date, whichever was earlier, or such other period that may be provided by regulation. However, if a study investigated a product that was not yet FDA approved, the FDAAA provided for the delayed posting of study results.

The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue for prescription drug products the US government is permitted to buy.

As companies that have or intend to commercialize products, including drugs and biologics, for sale to the US government are aware, the Trade Agreements Act (TAA) generally prohibits government purchases of certain foreign products. The Trade Agreements clause and related Trade Agreements certification, which are prescribed by regulation, are the principal clauses in government contracts—such as the VA Federal Supply Schedule (FSS) contract from which all government agencies purchase drugs—that effectuate this requirement. The clauses require companies to certify that products delivered under the government contract will be either manufactured in the United States or “substantially transformed” in the United States or a designated country, e.g., countries with which the United States has entered into trade agreements.

Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included into the Vital and Essential Drugs List, which is approved annually.

Under the Decree, foreign originators are required to constantly keep their prices in Russia in line with the lowest price in any of 12 foreign reference states, while the prices of generics and biosimilars should follow the prices of their reference drugs, less a reduction coefficient (except for orphan generics and biosimilars).

In addition, the Decree requires foreign and local pharmaceutical companies to go through a one-time mandatory ceiling price adjustment for all essential drugs in 2019-2020, except for immunobiological drugs, narcotic and psychotropic drugs, and drugs in the low-price segment (i.e., if the price does not exceed 100 Russian rubles), which are produced in the Eurasian Economic Union. A failure by the producer to go through the mandatory ceiling price adjustment will debar its drug from sale from January 1, 2021.

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.

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.