Fdca cont d
This presentation is the property of its rightful owner.
Sponsored Links
1 / 5

FDCA (cont’d) PowerPoint PPT Presentation


  • 96 Views
  • Uploaded on
  • Presentation posted in: General

FDCA (cont’d). Practice of Medicine The FDCA does not limit a physician’s ability to prescribe a drug for off-label use. FDCA (cont’d).

Download Presentation

FDCA (cont’d)

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Fdca cont d

FDCA (cont’d)

Practice of Medicine

The FDCA does not limit a physician’s ability to prescribe a drug for off-label use.


Fdca cont d1

FDCA (cont’d)

“While manufacturers may not themselves promote [off-label] uses, it is not unlawful for doctors to employ or prescribe medical products for “unapproved” uses. Indeed, the FDA claims that it has ‘long recognized the important role that some unapproved uses may play in the practice of medicine.’”Washington Legal Foundation v. Kessler, 880 F. Supp. 26, 28 n1 (D.D.C. 1995) (citing FDA’s memorandum supporting motion to dismiss).


Fdca cont d2

FDCA (cont’d)

“Once [a] new drug is in a local pharmacy after interstate shipment, the physician may, as a part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration.”37 Fed. Reg. 16, 503 (Notice of Proposed Rule Making) (Aug. 15, 1972).


Fdca cont d3

FDCA (cont’d)

Nor was it Congress’s intent in enacting the FDCA for the FDA to interfere with the practice of medicine: “Throughout the debate leading to enactment, there were repeated statements that Congress did not intend the Food and Drug Administration to interfere with medical practice and references to the understanding that the bill did not purport to regulate the practice of medicine as between the physician and the patient.”37 Fed. Reg. 16,503 (Aug. 15, 1972) (referring to the legislative history of the 1938 Act and the Drug Amendments of 1962).


Fdca cont d4

FDCA (cont’d)

Off-label use of a medical device “is an accepted and necessary corollary of the FDA’s mission to regulate . . . without directly interfering with the practice of medicine.”

Buckman Co. v. Plaintiff’s Legal Comm., 351 U.S. 341, 350 (2001).


  • Login