December 2003              return to newsletter contents page

AVDA Supports Petition to Continue Stay in Action Filed by Pharmaceutical Distributors Association

The AVDA Board recently lent support to a petition for continuation of the stay of action filed on November 30, 2003 by the Pharmaceutical Distributors Association (PDA) with respect to final regulations regarding certain Prescription Drug Marketing Act (PDMA) regulations. The current stay will expire on April 1, 2004 and the provisions of the final rule would go into effect if a further stay is not granted.

The matters of concern to AVDA members included the following. First, the definition of “Authorized Distributor” and second the requirement that the pedigree list transactions back to the manufacturer. If the final rules go in effect, only those firms which have a written agreement with the manufacturer will

have authorized distributor status – even if they have an ongoing business relationship with transactions on a weekly basis. The pedigree requirements call for all transactions to be recorded back to the manufacturer for all items sold by a company. But many companies buy not from manufacturers, but from one of the Big Three wholesalers who are Authorized Distributors of Record (ADRs). Since ADR’s are exempt from the requirement to provide a pedigree, those buying from them will not be able to resell the drugs with the required pedigree. Therefore, non-ADR’s will be precluded from doing business.

The Board felt that a further extension of the effective date of the final rule is needed to allow time for measures to be put in place to address these and other problems. The PDMA final rule has been extended four times.

Individual AVDA members are encouraged to contact the FDA in support of the Petition for Continuation of the Stay.

Send letters in support of the petition to:

Dr. Mark McClellan

Commissioner of Food and Drugs

U.S. Food and Drug Administration

5600 Fisher Lane

Rockville, MD 20817