(St. Paul, Minnesota) - Federal officials have published a proposal to place the pharmaceutical industry under ongoing federal scrutiny. December 2, 2002 is the last day for the public to comment on the proposal.

In public comments sent to the Office of Inspector General (OIG) today, Citizens' Council on Health Care (CCHC), a Minnesota-based health care policy organization, expresses concern that the proposal will lead to higher costs and reduced access to medication. Specific concerns include:

  • fewer free drug samples


  • tracking the activities of sales representatives


  • costs of compliance shifted to consumers and patients


  • diversion of funds from new drug research


  • disincentives for charitable distribution of medication


  • government-imposed price controls


  • micromanagement of private industry


  • intrusive oversight

"Suggesting that use of sales reps and distribution of free drug samples at doctor's offices could constitute health care fraud will undoubtedly lead to fewer free drug samples for those who depend on them," says Twila Brase, president of CCHC.

Brase says that Medicare recipients without drug coverage, the poor, and the insured with restrictive drug formularies who depend on free samples to meet their medication needs will be faced with less access and higher costs.

Brase also reminds federal officials about the impact of federal control over physician practices.

"Because of federal micromanagement and poor reimbursement, physicians are dropping Medicare participation in droves. We expect that drug companies will follow in their steps if the federal government decides to micromanage the pharmaceutical industry."

The Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers was published in the Federal Register on October 3, 2002. The OIG clarifies that the compliance with the guidance is voluntary but cautions the pharmaceutical industry that lack of compliance could lead to federal investigation and prosecution. In the last several years, guidances have been written for various other sectors of the health care industry.

"Medications are taking the place of hospitalizations, decreasing health care costs, and allowing patients to live longer, live better, and live at home. In an effort to cut costs to the Medicare programs, the guidance threatens the industry that is very important to patients. The public should be very worried," says Brase.

Deadline for public comments: 5 p.m. on Monday, December 2, 2002.


Office of Inspector General
Department of Health and Human Services
Attn: OIB-8-CPG
Room 5246, Cohen Building
330 Independence Avenue, SW
Washington, D.C. 20201

RE: OIGB - 8 - CPG


CCHC's public comments are available on the web site.

Media Contact:

Twila Brase, President and Co-founder
Office: 651-646-8935