HOUSE DEMOCRATS RAMP UP PROBE OF FDA APPROVAL OF ALZHEIMER’S DRUG

Democratic leaders of two House committees are stepping up a probe of the Food and Drug Administration’s (FDA) controversial approval of the Alzheimer’s drug Aduhelm, pressing the agency for information on “anomalies” in the approval process.

In a letter to FDA sent Wednesday, House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and Oversight and Reform Chairwoman Carolyn Maloney (D-N.Y.) said “significant questions” remain even after FDA staff briefed their panels.

The lawmakers launched the investigation in July, and requested a slew of documents from the pharmaceutical company Biogen over its Alzheimer’s treatment.

What they want to know: Among the information now sought by Pallone and Maloney is details on how FDA makes an approval determination when there is internal disagreement between agency staff as well as disagreement with the relevant advisory committee.

The lawmakers also questioned the agency’s interactions with Biogen during the review process, something that is also being reviewed by an independent government watchdog.