DRUG SAMPLING LEGISLATION CIRCULATING ON HILL: KENNEDY, KASSEBAUM PUSH FOR FULL BAN WITH SUBSTANTIAL COMPANY SUPPORT; APhA DEVELOPING PHARMACY OPTION

A legislative ban on pharmaceutical sampling is gaining momentum on Capitol Hill, with support from lawmakers and some drug companies.

Sens. Kennedy (D-Mass.) and Kassebaum (R-Kans.), ranking members of the Senate Labor Committee, are expected to introduce legislation imposing a complete ban on sampling in the near future. Final legislative language on the ban is being drafted.

While Kennedy and Kassebaum are understood to be committed to the concept of a full ban on sampling, suggestions have been made by certain drug companies and by pharmacy to allow continued sampling in some cases, such as for new drug products or starter packs. Bristol-Myers Squibb is said to support sampling within the first six months of marketing.

Another possibility for limiting samples -- restricting their use to starter packs that patients can only obtain through pharmacies -- has been suggested by the American Pharmaceutical Association. Rep. Brewster (D-Okla.), a pharmacist, may introduce a sampling bill shortly that would be based on the APhA proposal.

Because Brewster is not a member of the Energy & Commerce Committee, which has jurisdiction over FD&C Act issues, his bill cannot move far without help from within the committee. The issue of a sampling ban has attracted the interest of several members of the House who deal with drug issues, but Energy & Commerce Chairman Dingell (D-Mich.) is unlikely to make time in the committee's busy schedule for a specific drug industry bill until he is sure of the status of the larger health care reform proposal.

Ending the practice of sampling has garnered support from a wide array of drug companies. The prime argument turning more companies against the traditional marketing tactic is the cost of sampling. It is expensive, estimated to cost a large firm $150 mil. per year in packaging costs alone, and eliminating the expense seems to be an attractive option for companies looking to cut costs. Companies worry, however, that they would suffer a competitive disadvantage by being the first to end distribution of samples, and the industry is prevented by anti-trust concerns from agreeing together to stop.

Increased concerns about the costs of the PDMA implementing regulations and potential penalties from that reg appear to be another impetus for moving companies away from sampling. FDA's recent proposed reg implementing Dingell's Prescription Drug Marketing Act (the diversion act) estimates the extra paperwork resulting from the proposal will be $21.4 mil. for manufacturers ("The Pink Sheet" March 21, p. 5).

With the growing use of managed care for both private and public drag benefits, the usefulness of sampling for drug companies is also waning. Industry's willingness to reconsider its opposition to any ban on sampling was indicated recently by its being a topic of discussion by the Pharmaceutical Manufacturers Association board during its March 10 meeting ("The Pink Sheet" March 14, In Brief).