Responding to the growing pressure in Congress to bring more essential drug and device manufacturing back to the U.S., Jeff Francer, interim CEO and general counsel of the Association for Accessible Medicines (AAM), said the generic trade organization’s member companies will work with policymakers and other stakeholders to formulate policies addressing concerns the COVID-19 crisis has raised. To start the conversation, AAM on March 24 released basic principles for protecting patient access and diversifying the supply chain. One of those principles is that efforts to diversify must protect patient access to medicines in the short term while guaranteeing greater supply chain stability in the long term, Francer said. AAM and its member companies also pledged to work on policy measures that incentivize companies to diversify their supply chains. Additionally, they will support providing more transparency to regulators about the sources of their pharmaceutical ingredients so public health officials can better mitigate the risks of supply chain vulnerabilities such as over dependence on manufacturing in limited regions.
The International Coalition of Medicines Regulatory Authorities published a report Tuesday providing an overview of regulatory considerations related to COVID-19 vaccine development and the data required for regulatory decision-making. Stemming from a virtual workshop last week involving regulators from 17 countries, as well as the World Health Organization (WHO) and the European Commission, the report focused on two points – the preclinical data required to support the move to first-in-human trials and the need to address the theoretical risk that COVID-19 vaccines might enhance the disease prior to starting trials. The workshop, co-chaired by the EMA and FDA, also encouraged the sharing of information about vaccine development efforts.
Given the need for “unprecedented” collaboration in the time of COVID-19, the U.S. Federal Trade Commission (FTC) and Department of Justice (DoJ) issued a joint statement Tuesday to help companies engage in procompetitive collaboration that doesn’t violate U.S. antitrust laws. The statement clarifies what’s permissible, including collaborative R&D, the sharing of technical know-how and most joint-purchasing arrangements among health care providers. In addition to the guidance, the agencies said they would try to respond within seven days to COVID-19-related public health and safety requests submitted through the DoJ’s Business Review Process and the FTC’s Advisory Opinion Process. Normally, the response to such requests to evaluate proposed actions takes several months, according to the agencies. The agencies also pledged to expeditiously process joint venture filings under the National Cooperative Research and Production Act, which provides flexible treatment under antitrust laws for certain development organizations and joint ventures. While the agencies will crack down on those who fraudulently try to take advantage of the emergency or extend their monopolies, they said they will consider the pressing circumstances when evaluating efforts to address COVID-19. For instance, businesses may need to temporarily combine production, distribution or service networks to respond to the demand for medical supplies they may not traditionally manufacture or distribute. “These sorts of joint efforts, limited in duration and necessary to assist patients, consumers and communities affected by COVID-19 and its aftermath, may be a necessary response to exigent circumstances that provide Americans with products or services that might not be available otherwise,” the agencies said.
As the U.S. market reels to COVID-19, the SEC is reminding public companies of the importance of maintaining market integrity and following corporate controls and procedures. “Given these unique circumstances, a greater number of people may have access to material nonpublic information than in less challenging times,” Stephanie Avakian and Steven Peikin, co-directors of the SEC’s Division of Enforcement, cautioned Monday. “Those with such access … should be mindful of their obligations to keep this information confidential and to comply with the prohibitions on illegal securities trading.” The directors urged public companies to heed “their established disclosure controls and procedures, insider trading prohibitions, codes of ethics, and Regulation FD and selective disclosure prohibitions to ensure to the greatest extent possible that they protect against the improper dissemination and use of material nonpublic information.” Meanwhile, they said, the Enforcement Division will be committing “substantial resources” to protect investors from fraud and illegal trading practices.
The White House Monday announced the launch of the COVID-19 High Performance Computing Consortium to provide researchers worldwide with access to computing resources that could “significantly advance the pace of scientific discovery in the fight to stop the virus.” Spearheaded by the White House, U.S. Department of Energy and IBM, the public-private consortium includes government, industry and academic leaders who have volunteered free compute time and computer resources. Researchers will submit COVID-19-related proposals to the consortium via an online portal. Requests will be reviewed and matched with computing resources from one of the partner institutions. A panel of top scientists and computing researchers will work with the proposers to assess the public health benefit of the research and coordinate the allocation of the consortium’s computing assets, which can process massive numbers of calculations related to bioinformatics, epidemiology and molecular modeling, helping scientists develop answers to complex scientific questions about COVID-19 in hours or days vs. weeks or months, according to the White House.
Countries throughout the world are lagging behind on their commitment of ensuring access to tuberculosis (TB) preventive treatment to at least 24 million contacts of people with active TB and 6 million people living with HIV by 2022, according to WHO. “To date, only a fraction of that target has been reached,” the organization said Tuesday as it marked World TB Day by issuing new guidelines for TB treatment. The guidelines call for a scale-up of TB preventive treatment among populations at the highest risk, advise that either a tuberculin skin test or interferon-gamma release assay be used to test for TB infection and recommend new shorter options for preventive treatment in addition to the widely used six months of daily isoniazid. In Europe, rates of TB have dropped from 460,232 cases in 2010 to 269,859. However, Europe will need to accelerate its response to the disease if it’s to meet its 2030 goal of eradicating TB, WHO said.