July 19, 2002
The Honorable Judd Gregg
Dear Senator Gregg:
This is to express the opposition of the Association of American Physicians and Surgeons (AAPS) to S. 2394, the Clinton-Dodd-DeWine bill to codify the Pediatric Rule, which we have challenged in Court.
AAPS, a national association representing private physicians in all specialties, was founded in 1943. We espouse the sanctity of the patient-physician relationship and the Oath of Hippocrates, which enjoins physicians to prescribe according to the best of their ability and judgment, and to do no harm.
We believe that the Pediatric Rule does harm. It denies potentially life-saving drugs to patients of all ages, including seniors, until they can be tested on children-even drugs that are not intended for children. There are many practical and ethical difficulties in performing these tests on children, but these tests would be required under the Rule and this bill, and approval of new breakthrough medications would be delayed, unless an affirmative waiver is obtained on a case-by-case basis. Fully informed parents might be very wise to refuse consent to participate in such studies.
Testing does not assure safety. Experimental subjects can be harmed, and patients who receive approved drugs can also be harmed. Rare adverse effects will often not emerge in pre-marketing studies, but only later when the drug is in wide use. We believe that adults, not children, should bear the brunt of these unavoidable risks.
Children who receive a drug tested on adults, as an off-label prescription, arguably are at greater risk than children taking a drug that has already been extensively tested in a pediatric population. However, they are at no greater risk than an experimental subject would be, and they also reap the potential benefit of a more effective treatment. There is no reason to think that the supervision of a physician who is dedicated solely to patient welfare is less protective than that of a physician who is in the dual role of physician/researcher.
Physicians have a responsibility to monitor all patients carefully, regardless of how many tests have been done on the drugs they prescribe. Physicians cannot delegate this responsibility to the FDA. The thoroughness of pre-market tests and after-market surveillance, the total duration and extent of experience with a drug for various indications, and the available alternatives are all factors that a physician must weigh in writing a prescription. Congress should not shackle physicians and deprive their patients of treatments that their personal physicians deem best. Many lives have been saved, and much suffering relieved, with off-label uses of drugs.
The Pediatric Rule assures that more children will be subjected to risk without a commensurate benefit; that resources will be wasted; that costs will increase; and that the search for optimal treatment will be impeded.
At the same time that Congress is so concerned about the high cost of drugs, it is puzzling that it would consider legislation that would add still more to the tremendous cost of bringing new drugs to market. This cost must be measured in lives as well as dollars, both for patients who can't afford drugs and those who can't obtain them at any price due to FDA-imposed delays.
The expansion of FDA's misbranding, injunction, and seizure authority under S. 2394 presents concerns beyond the existing Rule. The failure to perform pediatric testing should not result in a lifesaving asthma medication, for example, being taken off the market. Even though the bill states that delay in submitting pediatric studies would not result in withdrawal of approval of that drug, seizure and injunction authority means that that drug could be pulled from the market and made unavailable to adults-even when the drug was not marketed for pediatric use.
Most importantly, we are appalled that this Rule, by the FDA's own calculation, exposes as many as 30% of the child subjects to needless risk.
This Rule and bill deserve a resounding defeat.
Jane M. Orient, M.D., F.A.C.P.