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More whistleblower protections:
As Vaccine Rollout Continues, What Whistleblower Protections Exist in Big Pharma?
By Carolyn Wheeler and Benjamin Tugendstein of Katz, Marshall & Banks, LLP
April 14, 2021
The nationwide rollout of the COVID-19 vaccine has continued to gain momentum some five months after the shot first became available to limited populations. In all 50 states, everyone above the age of 16 is either already eligible to receive the shot, or will become eligible shortly. On April 3rd, more than 4 million people in the U.S. received a vaccine, the highest one-day number to date. And the country seems on track to hit President Biden’s new goal of 200 million shots in his first 100 days in office which is April 30.
Despite all of this good news, there have been setbacks – the most serious of which was reported in early April. The New York Times revealed that Emergent BioSolutions, a biotech firm with a 628 million dollar contract with the federal government to manufacture COVID-19 vaccines, had to destroy up to 15 million doses of Johnson & Johnson’s Jenssen COVID-19 vaccine during the first week in April, after it was discovered the vaccine had been contaminated. That was not the first problem Emergent had with vaccine production. Between October 2020 and January 2021, the company also had to throw out between 10 and 15 million doses of the AstraZenaca vaccine because of contamination or suspected contamination. In November 2020, production of a batch of the Johnson & Johnson vaccine was discarded because of worker error, and records indicate that workers frequently deviated from manufacturing standards. As of now, federal regulators have yet to clear the Emergent facility, and therefore not a single dose of the 150 million doses it has produced has been distributed for public use.
Audits performed by federal regulators have found serious fundamental issues at the Emergent vaccine manufacturing facility and outside experts say that such recurring issues imply deep quality control problems.
Due to the urgency of the vaccine rollout, whatever the underlying causes of the quality issues at Emergent, given the huge amounts of money being awarded in the form of government contracts, there is potential for fraud and abuse in the manufacture of vaccines. Workers at Emergent and other manufacturing sites are in the best position to identify such issues, and should feel free to report safety and financial improprieties without fear of reprisal. Such whistleblowers who report abuse have various legal protections.
Protections for Pharmaceutical Whistleblowers
While there is no federal legislation that provides blanket protection for whistleblowers in the pharmaceutical industry from retaliation, there is a patchwork of federal and state laws that may do so, depending on the facts of the matter.
https://www.natlawreview.com/article/vaccine-rollout-continues-what-whistleblower-protections-exist-big-pharma