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Two US Food and Drug Administration meetings scheduled this week have been postponed, but the reasons for the changes remain a mystery as other public meetings remained on the agency calendar.

On 7 March, FDA officials told registrants for a Patient-Focused Drug Development meeting on stimulant use disorder that the event, scheduled for 10 March, had been postponed until further notice “due to extenuating circumstances.”

The half-day meeting at the Silver Spring, MD Civic Building was planned for people “struggling or who have struggled with the use of cocaine, crystal meth, or misuse of prescription stimulants like Adderall or Ritalin” to discuss the daily impacts of the disease, the impact of opioid and polysubstance use on their condition, and treatment goals.

The FDA did not respond to questions about the sudden change of plans, including whether the decision was based on the growing outbreak of coronavirus disease, also known as COVID-19, cases of which now have been found in the Washington, DC area.

A representative of the Silver Spring Civic Building also said that he had no information about the reasons for the event’s change other than “extenuating circumstances.”

Amid a stock market freefall spurred largely by coronavirus uncertainty, big pharma sought to reassure investors and the public that supply disruptions are not an immediate concern and they are monitoring business operations day-by-day.

The agency also postponed the 23rd US-Japan Cellular and Gene Therapy Conference, which was scheduled for 12 March at the FDA’s headquarters in White Oak, MD, citing “extenuating circumstances.” No make-up date was announced.

Multiple scheduled presenters at that meeting told thePink Sheet that they were not provided a specific reason for the postponement. One received no formal information, and another said they were told “extenuating circumstances.”

The postponements came as many medical meetings and other large events have been cancelled and employers restrict travel and make other arrangements out of fear of the coronavirus. Hundreds of cases and several deaths have been reported across 35 states including Washington, DC, according to the US Centers for Disease Control and Prevention.

Multiple companies also are implementing infection control measures. Biogen Inc. has told employees in several offices to telework after a COVID-19 case was traced to an internal company meeting. (Also see "Biogen Linked To More Coronavirus Cases In Boston" - Scrip, 9 Mar, 2020.)

Eli Lilly & Co. also reportedly told its employees to telework and is restricting domestic travel as a precaution to prevent exposure to the virus. (See sidebar.)

Other Meetings This Week Continue

However, other FDA meetings went on as scheduled or have not been adjusted.

An FDA joint meeting with the Federal Trade Commission on the competitive marketplace for biosimilars continued as scheduled on 9 March at White Oak.

A same-day Center for Devices and Radiological Health workshop on detecting circulating DNA for cancer screening, as well as an 11 March Nonprescription Drugs Advisory Committee meeting remained scheduled, according to the FDA’s website. Both will be held at White Oak.

FDA meeting cancellations or postponements are not unprecedented. The agency admitted in 2016 that a snowstorm forced an advisory committee meeting to be rescheduled. (Also see "Sarepta's Duchenne Treatment Likely Making Progress At FDA" - Pink Sheet, 8 Feb, 2016.)

Woodcock Reminds Staff To Be Vigilant

Center for Drug Evaluation and Research Director Janet Woodcock also praised her staff on 6 March for its work on the coronavirus outbreak while also warning that they should remain vigilant.

Agency US Public Health Service Commissioned Corps. officers have been called to help with efforts to fight COVID-19’s spread and several others are addressing emergency INDs, supply chain and drug shortage work, legislative proposals, stakeholder communications, and “continuity of CDER business operations,” Woodcock wrote in a memo to staff.

Woodcock said that she deeply appreciated their “dedication and flexibility during this intense time, especially because our coronavirus activities affect the whole center and require close collaboration with various parts of the agency and other federal and international partners.”

She also reminded staff that if they believe they have the flu or have been exposed to other viruses, that they see a health care provider and make arrangements for sick leave or to use “alternative workplace options”, such as telework.

The FDA also has advised potential visitors to its White Oak headquarters and other buildings that they could be asked questions related to recent international travel before entering. (Also see "For Coronavirus, US FDA Is At The Podium But Not On The Task Force" - Pink Sheet, 9 Feb, 2020.)

Virus Brings Review, Oversight Challenges For FDA

Agency officials are directly involved in review and approval of COVID-19 diagnostic tests, which after some problems are being shipped to public and clinical labs throughout the US. (Also see "LabCorp Launches COVID-19 Testing, Quest Diagnostics Will Provide Testing Starting 9 March In US" - Medtech Insight, 6 Mar, 2020.)

In addition, the agency is monitoring the drug supply chain for shortages that could arise due to manufacturing slow downs in China and other countries affected by the virus. One COVID-19 related shortage has been disclosed, although the agency will not state the name of the drug.

The prospect has restarted calls for legislation that would mandate manufacturers provide more help for FDA anticipate and prevent shortages. (Also see "Drug Shortage Legislation Gains Support As Coronavirus Threatens US Supplies" - Pink Sheet, 8 Mar, 2020.)

Vaccines and therapeutic candidates also are in development. Gilead Sciences Inc.’s nucleotide analogue remdesivir is in clinical trials in China and the US, and Moderna Inc.’s messenger RNA candidate vaccine is moving into phase I trials. (Also see "US Biopharma ‘Consortium’ Promises Array Of Coronavirus Remedies" - Pink Sheet, 3 Mar, 2020.)

The development rush has prompted calls to ensure that any approved therapeutics or vaccines for COVID-19 be affordable. (Also see "Buying The Coronavirus Vaccine: What Would A ‘Fair And Reasonable’ Price Be?" - Pink Sheet, 6 Mar, 2020.)

FDA Issues First Warning Letters For Unapproved COVID-19 Products

FDA officials also are monitoring for counterfeit products or false claims related to COVID-19. The agency, along with the FTC, on 9 March announced seven warning letters had been sent to companies selling products claiming to prevent or treat the virus. The FDA said the products in question were unapproved drugs and pose significant risk to patient health.

FTC Chairman Joe Simons said in a statement that the agency is prepared to take “enforcement actions against companies that continue to market this type of scam.”

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