Draft Guidance for Industry: ``Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits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

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Draft Guidance for Industry: ``Promoting Medical Products in a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a notice announcing the availability of a draft guidance for industry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this draft guidance and to allow interested parties additional time to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ADDRESSES: Copies of the draft guidance for industry are available on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written requests for single copies of the draft guidance for industry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