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Wednesday, Aug 14 2024

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Perspectives: Pharmaceutical Testing Facility Gave Fraudulent Data. Why Didn't FDA Withdraw Approval?

Read recent commentaries about pharmaceutical issues.

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. Instead, it has allowed these drugs to continue to be prescribed and distributed for at least a year as the pharmaceutical companies retest them for equivalency to the original brand-name drugs. (Suzanne Robotti, 8/12)

Pharmacy benefit managers have been in the crosshairs of late, as the focus of media scrutiny, government investigations and reports, and proposed federal legislation. A few recent examples make the point: A New York Times story in June 2024 bore the headline, 鈥淧harmacy benefit managers are driving up drug costs for millions of people, employers and the government.鈥 (T. Joseph Mattingly II, David A. Hyman and Ge Bai, 8/12)

Pharmaceutical leaders face competing pressures. Their companies are expected to develop products that reduce the burden of disease and make the enjoyment of the highest attainable standard of health 鈥渙ne of the fundamental rights of every human being.鈥 (Fred D. Ledley, 8/7)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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