Ex-FDA Chief: Inflation Reduction Act Causing Drug Shortage

Former Food and Drug Administration Commissioner Scott Gottlieb has issued a warning about the potential for increased drug shortages due to the recently enacted Inflation Reduction Act. The FDA has reported around 130 drugs are currently in short supply.

In a recent interview on CBS News’s Face the Nation, Gottlieb clarified these shortages primarily affect sterile injectable drugs, including critical treatments like those used in cancer care. The Inflation Reduction Act has implemented price caps on pharmaceuticals, a measure that Gottlieb believes will worsen the problem.

Dr. Scott Gottlieb on “Face the Nation” | extended interview

He explained, “The provisions outlined in the Inflation Reduction Act will exacerbate this problem, as it will hinder generic manufacturers from implementing price increases.” He further elaborated, stating manufacturers would be unable to adjust prices to offset expenses associated with market entry or facility upgrades in order to meet rigorous regulatory standards.

Consequently, they will have to bear these costs themselves, potentially impacting their operations and contributing to drug shortages. Gottlieb noted the significance of sterile injectable drugs and the need for a financial margin in their production.

He stressed the necessity for companies to allocate funds for reinvestment in manufacturing facilities, ensuring they maintain the highest quality standards. Failure to do so can result in unforeseen complications and subsequently contribute to the scarcity of these vital medications. An example of a drug facing an extreme shortage is Ozempic, a crucial treatment for diabetes.

Analysis conducted by JPMorgan revealed health providers prescribed over 313,000 doses of Ozempic during the last week of January. This figure represents a significant 78% increase compared to the 176,000 prescriptions issued during the same period the previous year.

As the pharmaceutical industry grapples with these challenges, stakeholders must consider the delicate balance between affordability and accessibility of life-saving medications. Addressing the underlying causes of drug shortages will be crucial in safeguarding public health and ensuring patients have access to the treatments they need.

The impact on sterile injectable drugs and the challenges faced by generic manufacturers underscore the need for careful consideration of pricing policies. As the healthcare industry navigates these issues, finding solutions that ensure the stability of drug supplies and prioritize patient well-being will be critical.

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