DRUG DIVERSION LEGISLATION IN 100th CONGRESS: PMA SEEKING "SAFETY VALVE" PENALTY EXEMPTION FOR FIRMS TAKING REASONABLE STEPS TO PREVENT SAMPLING ABUSES

PMA will support drug diversion legislation in the next Congress if it includes a "safety valve" provision to exempt firms from penalties for employee drug sampling violations which are beyond the ability of companies to prevent, PMA President Mossinghoff said at a Nov. 25 press conference. "I think there was general agreement on the part of PMA and congressman Wyden [D-Ore.] and" the staff of House Energy & Commerce Committee Chairman Dingell (D-Mich.) "that there should be some safety valve if a company has done everything possible to have a diligent, rigorous system," Mossinghoff said. "There ought to be some safety valve for a company to avoid" penalties. The bill Dingell offered in the last Congress contained a penalty of up to $1 mil. for three convictions within a 10-year period of sales personnel for violations involving drug samples ("The Pink Sheet" Oct. 13, p. 3). PMA VP-Congressional Relations Geoffrey Littlehale said the association is "working very hard to come to a compromise" on a new bill and noted that negotiations on last year's measure came "literally down to a line or two" out of a 25-30 page bill. Mossinghoff said PMA is focusing "on what kind of safety valve could be included so that a company that acted responsibly by everyone's agreement would not suffer this penalty," Mossinghoff said. "What we are actually talking about is more proof on the part of the company that it did everything reasonable to avoid" a violation. Mossinghoff indicated that the Democratic shift in the Senate, particularly Sen. Kennedy's (D-Mass.) regaining the chairmanship of the Labor & Human Resources Committee, would have a negligible effect on the legislative effort toward a drug diversion bill. "We've thought long and hard about that. My own view . . . is that we have good relations with Sen. Kennedy and his principal staff people; we have worked very hard with them . . . to pass the omnibus [health care] bill," the PMA president said. "As I view the situation, we have very good relations with Sen. Kennedy and continuing good relations with Sen. Hatch [R-Utah, former committee chairman], so I would say that it is probably neutral." To demonstrate support for its position on the benefits of Rx drug samples, PMA contracted for a survey on physician attitudes toward samples. Conducted by the National Analysts Division of Booz Allen, the poll of 604 doctors found that distribution of samples to patients "is fairly restrained," the association noted. The report states that "on average only one out of five patients receives a complimentary prescription drug sample" and that "seven out of 10 sampling occasions result in a prescription for the sampled medication." In addition, the study found that "on most sampling occasions, the drug sampled is one which the doctor has frequently used before." PMA concluded that "physicians attach greater importance to assessing efficacy and side effects when the drug is new to the patient, rather than new to the doctor." Physicians were also asked their opinion about three potential alternatives to current sampling procedures: requiring written request, requiring receipts signed by the doctor for samples received, and replacing samples with coupons. "The coupon proposal was strongly rejected, while physicians split almost evenly on written requests and appear to be willing to tolerate signed receipts," the study reports. More than "eight out of 10 physicians believe that distributing coupons would be inferior to the current system," the report states. The poll found that the most frequently cited reason for opposing coupons is "a concern that coupons will be more difficult to efficiently store and access than are drug samples." Use of coupons is not a totally new idea; "close to two-thirds of all physicians have received sample coupons in the past six months, yet fewer than half of those receiving coupons have given any to patients," the study reports. Other legislative priorities for PMA during the 100th Congress include trade legislation, further tax reform amendments, FDA funding, and process patent law reform. Littlehale noted that the association was only "modestly involved" in a trade bill last year because chances for passage did not seem "very great." However, there "almost certainly" will be some sort of trade bill in 1987, and PMA will "pursue it very aggressively," he said, adding that the association currently is putting together the "internal decisionmaking mechanisms" needed to respond to congressional initiatives.