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FDA Allows Pharmacies to Compound Drugs to Fill Hospitals’ Needs

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health emergency, or for a shorter time as FDA may announce.  In an effort to mitigate actual or anticipated drug shortages for 13 drugs products needed to support the care of hospitalized COVID-19 patients, mostly ventilator-related drugs,...

CMS Has Invoked Its “Extreme and Uncontrollable Circumstances” Policy to Offer ACOs Some Degree of Relief During the COVID-19 Crisis – But What About Your Commercial Shared Savings Contracts?

In a March 30th, 2020 proposed Interim Final Rule (“IFR”), CMS declared that it would be applying (and, later, expanding the scope of) its “extreme and uncontrollable circumstances” regulation, 42 C.F.R. 425.502(f), to “mitigate any impact on quality performance and the resultant effect on financial reconciliation due to” the COVID-19 crisis, which was recognized as an “emergency circumstance outside of . . . [Accountable Care Organizations’ (“ACO”)] control.” See https://www.cms.gov/files/document/covid-final-ifc.pdf....

Manufacturer ALERT: U.S. and Global Pharmaceutical Companies Making Progress in Race to Approve COVID-19 Vaccine

As Coronavirus (COVID-19) cases continue to plateau and as the nation experiences the benefit of social distancing, the focus has quickly turned to the development of a vaccine.  Promising Vaccines Despite the substantial cost of developing, distributing and administering vaccines in a highly regulated industry, manufacturers and research institutions have been spending heavily on their development recently. According to the Wall Street Journal, Moderna and Pfizer are collaborating on Messenger...

DOJ Shifting Focus to Prosecute COVID-19 Related Fraud

The COVID-19 Pandemic has caused a significant shift in the way we all do business. Its effect on the Government has likewise been profound. In response to the Pandemic, U.S. Attorney General Barr announced a shift in priorities in a March 16, 2020 memorandum: “[t]he [COVID-19] pandemic is dangerous enough without wrongdoers seeking to profit from public panic and this sort of conduct cannot be tolerated. Every U.S. Attorney's Office...

The Risks of Distributing COVID-19 Therapies: What Wholesale Distributors Need to Know About Track and Trace

Wholesale drug distributors need to maintain adequate track and trace documents, especially when acquiring and distributing COVID-19 therapies. The COVID-19 epidemic has sparked a demand for various drug products including, hydroxychloroquine. To ensure adequate supply, some countries have gone so far as to institute full-scale lockdowns on the exportation of this and other drugs. With the ever-increasing demand for COVID-19 therapies, wholesale distributors may find themselves on the receiving end...