To Avoid Pandemic Drug Shortages, The FDA Bent Its Own Rules, Priorities
A report in CIDRAP explains how the Food and Drug Administration tried to prevent drug shortages by "flexing" its rules and expedited new drug applications and supplements. Separately, reports note Pfizer's heart meds are bringing in billions of dollars for the drugmaker.
CIDRAP:
FDA Went Flexible To Mitigate Shortages During COVID-19
The COVID-19 pandemic caused the US Food and Drug Administration (FDA) to flex regulations and priorities to prevent drug shortages, expediting more than 100 original abbreviated new drug applications (ANDAs) and 150 ANDA supplements for COVID-related products, according to the FDA's "Drug Shortages for Calendar Year 2020" report, released late last month. The agency reported 43 new shortages but prevented 199, compared with 2019's 51 new shortages and 154 prevented shortages. On the other hand, 2020 had 86 ongoing shortages, compared with 76 in 2019. (McLernon, 7/7)
Axios:
Pfizer's Rare Heart Disease Drug Vyndaqel Is Becoming A Blockbuster
Heart medications Vyndaqel and Vyndamax generated $1.3 billion of global revenue last year for Pfizer and already brought in $453 million in the first quarter of this year. Why it matters: The blockbuster drugs could grow significantly more if Pfizer wins its pending lawsuit and is allowed to pay the out-of-pocket expenses of Medicare patients who are prescribed the $225,000-a-year treatment. (Herman, 7/8)
In legal developments —
AP:
Pharmacy Exec Resentenced To 14 Years In Meningitis Outbreak
A founder of a now-defunct Massachusetts pharmaceutical facility responsible for a deadly meningitis outbreak will spend 14 and a half years behind bars, a federal judge ruled Wednesday, lengthening his initial punishment of nine years that was tossed out by an appeals court. Barry Cadden, who was president and co-owner of the now-closed New England Compounding Center, showed little emotion as he was sentenced for a second time after being convicted of fraud and other crimes in the 2012 outbreak that killed 100 people and sickened hundreds of others. (Richer, 7/7)
Axios:
Industry Awaits Ruling Of Pfizer's Medicare Anti-Kickback Lawsuit
A federal judge will soon determine whether Pfizer can pay Medicare patients' out-of-pocket expenses for one of its heart medications that is priced at $225,000 per year. Why it matters: A ruling in Pfizer's favor would legalize something that is viewed as a kickback under current law, and would jeopardize taxpayer coffers by spurring a "gold rush" of pharmaceutical companies to cover Medicare copays for expensive drugs. (Herman, 7/8)
The Wall Street Journal:
Theranos Founder Elizabeth Holmes Renews Fight To Constrain Prosecutors
Lawyers for Theranos Inc. founder Elizabeth Holmes asked a federal judge to place new restrictions on the scope of evidence that prosecutors can present at her coming criminal-fraud trial, arguing her defense is hampered by the loss of a database with millions of blood-test results. (Randazzo, 7/7)
