More federal regulators investigating Biogen's Alzheimer's drug | BioPharma Dive
More federal regulators investigating Biogen's Alzheimer's drug
Dive Brief:
More federal regulators investigating Biogen's Alzheimer's drug
Dive Brief:
- Having already come under scrutiny from the U.S. government, Biogen's recently approved treatment for Alzheimer's disease is now also on the radar of two more federal agencies that want information about how the drug gained approval and how it's been marketed since.
- In a regulatory filing Thursday, Biogen said the Federal Trade Commission had sent a type of subpoena known as a "civil investigative demand," looking for more details about the drug, called Aduhelm. The company said it has also received an inquiry related to Aduhelm from the Securities and Exchange Commission.
- These requests affirm that federal regulators remain intently focused on Biogen's drug and the unusual circumstances surrounding its approval. Shortly after it was cleared for market last June, two committees in the House of Representatives launched a joint investigation to examine Aduhelm's approval and pricing. The U.S. health department's inspector general is also looking into the processthat the Food and Drug Administration used to approve Aduhelm.