Buried in a bill recently passed by the U.S. Senate are provisions that may cause doctors, and all of their patients, some long-term heartburn.

Under the Prescription Drug User Fee Amendments of 2007, known as the Kennedy-Enzi bill, firms such as Pfizer and Merck will continue to pay the Food and Drug Administration to review new pharmaceuticals and medical devices to ensure their safety, a worthy purpose of government. On the surface, it is not surprising that the bill passed by a vote of 93-1.

Part of the bill is a response to the harmful side effects some individuals can experience in otherwise highly effective drugs that can help millions of patients. Vioxx is such an example. Merck, the maker of Vioxx, faces litigation for substantial liability from the drug.

At the heart of the matter is an ethical dilemma for contemporary medicine: How do we make available ever-improved pharmaceuticals that have enormous benefits to the majority of patients but are dangerous for others? The right answer has at least two parts. First, we need to do a better job of monitoring both the good results and the unintended consequences of prescribed drugs. Second, and in addition, we need to limit liability from unintended consequences for otherwise effective drugs so that innovators are not discouraged from developing new and effective drugs.

The Kennedy-Enzi bill provides only a partial answer. It would lead to the monitoring of some, but not necessarily all, drugs, and it would do nothing to encourage the development of new drugs. Indeed, the results of the federal monitoring activities, which would be paid by fees raised from drug manufacturers, could become Exhibit A in litigation against those very manufacturers.

Perhaps even worse, the Kennedy-Enzi bill would create a new form of federal regulation of the medication profession. The bill provides for the secretary of the Department of Health and Human Services, likely through the FDA, to develop risk assessment plans and mitigation strategies to assure safe access to drugs. For drugs with known serious risks, the secretary of HHS would be given the authority to determine which doctors could prescribe which medications as well as the authority to determine specific dosages and purposes for which medications can be prescribed.

For instance, the FDA could determine particular training, experience, or certification for health care professionals to prescribe or administer certain drugs. The criteria for these decisions are not specifically articulated and do not contain a reference to medical degree or specialty. Doctors would be monitored and evaluated to ensure safe usage. Doctors’ offices would likely be required to obtain information from patients, pharmacists, and other doctors and health care providers to provide to the FDA.

The bill puts the federal government for the first time in the business of assessing and even licensing who is a medical professional. The medical profession is traditionally self-regulated by state professional licensing departments and professional medical societies. Under Kennedy-Enzi, federal certifications might soon be framed on your doctor’s wall.

HHS and the FDA are not wellsuited to regulate the medical profession, nor is such regulation necessary for drug safety. For example, Senator Grassley has introduced a similar bill, the Food and Drug Administration Safety Act of 2007, which also attempts to tackle the arduous task of drug safety but without regulating health care providers.

Over the past 50 years, the federal government has inexorably taken control over much of the medical profession. By financing medical services under Medicare and Medicaid and financing research under the National Institutes of Health, the federal government has enormous influence on the provision of health care. Managers of hospitals and medical schools today are likely to be more familiar with the frontiers of federal laws and funding sources than the frontiers of medicine. It need not be that way.

Improving drug risk-benefit information is important. So too is monitoring the effects of drugs once prescribed. To perform these services, the federal government does not need to take the giant and ill-advised step of regulating doctors and other health care providers. In creating new information on the risks and benefits of drugs, Congress should ensure that incentives remain to develop those drugs rather than simply creating a Federal Doctors’ Administration.

A former FCC commissioner, Mr. Furchtgott-Roth is president of Furchtgott-Roth Economic Enterprises. He is organizing the seminar series at the Hudson Institute. He can be reached at hfr@furchtgott-roth.com.