Comment Letter

Neurosurgery Joins Coalition in Commenting on FDA Off-Label Guidance

  • Drugs and Devices

Lauren K. Roth
Associate Commissioner for Policy
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Submitted electronically via

Re: Communications From Firms to Health Care Providers Regarding Scientific Information on
Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers

Dear Associate Commissioner Roth:

The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty physicians from 16 specialty and subspecialty societies who are dedicated to the development of sound federal health care policy that fosters patient access to the highest quality specialty care. We appreciate the opportunity to provide feedback regarding the aforementioned second revised draft guidance from the perspective of specialty physicians.

Physician-directed applications of approved or cleared medical products (i.e., “off-label” uses) are integral to specialty medicine. For the conditions specialists diagnose, manage, and treat, physician directed applications may be widely recognized as the standard of care and recommended in practice guidelines. As explained in our position statement,

To enhance patient care, physicians must have unrestricted access to truthful, non-misleading information about the benefits and risks of all therapies available for treatment, including medically accepted alternative uses of approved prescription drugs, biologics, and/or devices. Manufacturers must be able to provide adequate directions for use of both approved and medically accepted alternative indications of approved medicines and treatments, along with adequate disclosures regarding risks and the limitations of scientific understanding.

We commend FDA for making a concerted effort “to strike a careful balance between supporting [health care providers’] interest in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient, and mitigating the potential that the government interests advanced by these statutory requirements will be undermined,” in this second revised draft guidance.

Click here to read the full Neurosurgery Joins Coalition in Commenting on FDA Off-Label Guidance.