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

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 Administration for Market Regulation of Jing’an District in Shanghai (AMR) on May 7 announced an administrative penalty decision against the Shanghai branch of a multinational pharmaceutical company for speaking fees it paid to physicians. According to the decision, the AMR found that the speeches in question never actually occurred and that the “speaking fees” were actually bribes. The AMR held that the physicians had utilized their official positions to unduly influence patients to purchase medical products promoted by the company branch, and that the payment of the fees constituted commercial bribery in violation of Article 7, Section 1(i) of the Anti-Unfair Competition Law of the People’s Republic of China.

The payment of speaking fees in the pharmaceutical industry has attracted heightened scrutiny from the Chinese government in recent years, and this case is not the first time the Shanghai AMR has targeted the practice. Read the full LawFlash for more details.

The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law. To succeed on a pre-emption defense on failure-to-warn claims, the drug manufacturer must present “clear evidence” that it fully informed the US Food and Drug Administration (FDA) of the justifications for the warning, and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve the addition of the warning to the drug’s label. The Court remanded to the US Court of Appeals for the Third Circuit to decide the pre-emption question. Two concurring opinions provide the Third Circuit with roadmaps to opposite conclusions.

Read the full LawFlash.

In the wake of several high-profile incidents regarding data privacy and the misuse of genetic and personal information, including the case of a Chinese scientist who attracted worldwide criticism after reportedly creating the world’s first human babies whose DNA is genetically modified, the Chinese government has recently issued several top-level policy directives reaffirming its commitment to strengthening cybersecurity and the protection of personal data and human genetic information and material. Though driven by recent events, these policy directives are intended to build upon and further strengthen already existing protections enshrined in the country’s constitution and Tort Liability Law, a process that had already begun with the passage of the country’s Cybersecurity Law (CSL) and General Principles of Civil Law in recent years. Specifically, the recent policy directives place strict prohibitions on the unauthorized use of human genetic material for research purposes and create administrative penalties for the unlawful cross-border transfer of genetic information, while simultaneously streamlining the regulatory approval process for such transfers in an effort to mitigate the impact of increased regulation on international cooperation within the life sciences industry.

Read the full LawFlash.

Although federal efforts on drug pricing remain at the proposal stage, recently enacted legislation in six states on drug price transparency requires pharmaceutical manufacturers to review and update their approaches to prescription drug pricing and price increases on an ongoing basis to ensure compliance with state laws. Beginning in 2019, some states will impose penalties for noncompliance with reporting obligations. The state statutes raise various concerns, including that they vary from state to state, are often unclear as to what products are covered, and use different calculation methods and evidence to support price increases.

Read the full LawFlash.