[Federal Register Volume 63, Number 126 (Wednesday, July 1, 1998)]
[Notices]
[Pages 35937-35938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17413]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0525]


Draft Guidance for Industry: ``Promoting Medical Products in a 
Changing Healthcare Environment; I. Medical Product Promotion by 
Healthcare Organizations or Pharmacy Benefits Management Companies 
(PBMs);'' Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is reopening until July 
31, 1998, the comment period for

[[Page 35938]]

a notice announcing the availability of a draft guidance for industry 
entitled ``Promoting Medical Products in a Changing Healthcare 
Environment; I. Medical Product Promotion by Healthcare Organizations 
or Pharmacy Benefits Management Companies (PBMs)'' that appeared in the 
Federal Register of January 5, 1998 (63 FR 236). FDA is taking this 
action because of the complexity and importance of the issues raised by 
this draft guidance and to allow interested parties additional time to 
prepare and submit comments.

DATES:  Written comments by July 31, 1998. General comments on agency 
guidance documents are welcome at any time.

ADDRESSES:  Copies of the draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance for industry 
``Promoting Medical Products in a Changing Healthcare Environment; I. 
Medical Product Promotion by Healthcare Organizations or Pharmacy 
Benefits Management Companies (PBMs)'' to the Drug Information Branch 
(HFD-210), Center for Drug Evaluation and Research, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
request. Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Requests and comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding prescription drugs: Laurie B. Burke, Center for Drug 
Evaluation and Research (HFD-40), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2828, or via Internet at 
[email protected];
    Regarding prescription biological products: Toni M. Stifano, Center 
for Biologics Evaluation and Research (HFM-200), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via Internet at [email protected];
    Regarding restricted medical devices: Byron L. Tart, Center for 
Devices and Radiological Health (HFZ-302), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4639, or 
via Internet at [email protected].
SUPPLEMENTARY INFORMATION:  In the Federal Register of January 5, 1998 
(63 FR 236), FDA published a notice announcing the availability of a 
draft guidance for industry entitled ``Promoting Medical Products in a 
Changing Healthcare Environment; I. Medical Product Promotion by 
Healthcare Organizations or Pharmacy Benefits Management Companies 
(PBMs).'' The draft guidance is intended to assist sponsors of 
regulated medical products (human drugs, biologics, and medical 
devices) by describing circumstances in which they may be held 
responsible for promotional activities performed by a healthcare 
organization/PBM subsidiary or by a nonsubsidiary healthcare 
organization/PBM that violate the Federal Food, Drug, and Cosmetic Act 
and regulations issued thereunder. The draft guidance also reminds 
medical product sponsors of their responsibility to submit or, in the 
case of some devices, maintain historical files of promotional labeling 
and advertising. Following the review of all comments received between 
January 5 and July 31, 1998, the agency intends to solicit public 
comment on a new draft guidance document.
    Interested persons may, on or before July 31, 1998, submit to the 
Dockets Management Branch (address above) written comments on this 
subject. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 25, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17413 Filed 6-30-98; 8:45 am]
BILLING CODE 4160-01-F