Recognizing that COVID-19 will affect all the members of the European Medicines Regulatory Network, albeit to a different extent and not necessarily at the same time, the EMA, EU member states and the European Commission released a business continuity plan Thursday detailing how core regulatory activities will be carried out during the pandemic. The plan acknowledged that the magnitude of the additional regulatory work due to the pandemic is difficult to quantify at this time. “The extent of the impact on the pharmaceutical industry is also unknown, including whether it will result in a reduction or delay of submissions,” according to the plan. “Even if there is a reduction in submissions, it might not be at the same time as the increase in COVID-19-related submissions, and any delays might result in a cumulation of submissions at a later stage.” While delays to the assessment of new non-COVID-19-related drugs must be mitigated as far as possible, “under no circumstances can the assessment of medicines used to treat or prevent COVID-19 be delayed,” according to the plan. The plan also gives priority to other drugs needed to treat COVID-19 patients and to procedures to minimize shortages caused by the pandemic. The plan identifies three phases of response based on the regulatory capacity and resources available to deal with the demand and then outlines how national and EU regulators should respond in each phase by providing back up for each other.
Canadian Minister of Health Patty Hajdu issued an interim order Wednesday providing new flexibilities to accelerate clinical trials for potential COVID-19 therapies, devices and vaccines. The order expands who can conduct a drug trial beyond doctors and dentists to include other health care professionals such as nurse practitioners, according to Health Canada. It also allows doctors to serve as investigators in device trials, a role normally restricted to manufacturers. Other changes include reducing the burden associated with labeling and record-keeping requirements for clinical trials involving approved drugs that are being studied for a COVID-19 indication, enabling multiple-stream trials to continue even when one stream is stopped and allowing trials where direct interaction with the participant isn’t feasible. To date, Health Canada has approved 37 clinical trials for potential COVID-19 products.
In light of the hardships COVID-19 is imposing on small businesses and individual inventors, the U.S. Patent and Trademark Office (USPTO) is, for the third time, extending the deadlines for filing certain patent documents and paying fees. But this time the extension is only for small and micro entities. Under the extension, filings and payments due between March 27 and June 1, 2020, will now be due by July 1. After this month, large entities "should seek relief on a case-by-case basis, through the filing of a petition for an extension of time or a petition to revive, accompanied by any required fee," according to a USPTO notice.
A bill giving the directors of NIH institutes the same job protection as the heads of other independent U.S. agencies enjoy was introduced Wednesday in both the House and Senate. The National Institutes of Health Director Protection Act would ensure that heads of the NIH research institutes can only be removed for malfeasance, neglect of office or incapacity. House sponsors of the bill – Reps. Peter Welch (D-Vt.), Stephen Lynch (D-Mass.) and Gerry Connolly (D-Va.) – pointed out that the heads of agencies such as the Federal Trade Commissions and Social Security Administration already have that protection. The bill stems from concerns that Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, could be fired for providing scientific advice on dealing with COVID-19. Appointed to his position in 1984 under President Ronald Reagan, Fauci has served under six presidents – four Republicans and two Democrats. President George W. Bush awarded him the nation’s highest civilian honor, the Presidential Medal of Freedom.
The congressional Blue Dog Coalition wrote this week to U.S. House and Senate leadership, calling for a federal inquiry into the actions of the Chinese Communist Party at the onset of the COVID-19 outbreak and into how it might try to exploit the pandemic to advance its foreign policy objectives to the detriment of the U.S. and its allies. The coalition also endorsed legislation to establish a bipartisan commission to assess the U.S.’ preparation for and response to the pandemic, the Chinese government's errors at the onset of the outbreak and the U.S.’ over-reliance on China for critical supplies.
The U.S. Government Accountability Office (GAO) said the Centers for Medicare and Medicaid Services is among four federal government agencies that have imposed conflicting cybersecurity requirements upon states that receive data from those agencies. The three other agencies in the GAO report are the IRS, the FBI and the Social Security Administration. The report said the agencies have promulgated policies for cybersecurity requirements that were at odds with those developed by the other three agencies by as much as 79%. A survey of state cybersecurity offices disclosed that the states experienced elevated cybersecurity compliance costs due to the unaligned cybersecurity policies, although the report also noted that the differences in cybersecurity policies are to some extent justified by differences in the agencies’ missions. GAO urged the White House Office of Management and Budget to encourage the agencies to align their policies where feasible and recommended that the CMS revise its policies for assessing state cybersecurity requirements to maximize coordination with the other agencies “to the greatest extent practicable.”