New PDMA regulations take effect

December 1, 2000

Pharmaceutical Representative

By the time this issue of Pharmaceutical Representative reaches its readers, the new Prescription Drug Marketing Act regulations will finally have taken effect.

By the time this issue of Pharmaceutical Representative reaches its readers, the new Prescription Drug Marketing Act regulations will finally have taken effect. Pharmaceutical Representative spoke with Margaret O'Rourke, Prescription Drug Marketing Act senior regulatory expert for the Food and Drug Administration's Center for Drug Evaluation and Research, to find out exactly how the new regulations will affect the jobs of pharmaceutical sales representatives and what representatives need to know to make sure they are in compliance with them.

PR: What is the history of the current regulations?

FDA: The regulations were initially published in the Federal Register of March 14, 1994, as proposed regulations. The comment period for these proposed regulations was extended to August 31, 1994. Due to agency involvement with other matters, particularly implementation of the FDA Modernization Act, these regulations were not published in final form until December 3, 1999.

FDA: That the regulations require drug manufacturers or authorized distributors to develop and implement a sample distribution security and audit system by December 4, 2000, and that the FDA will be inspecting to determine whether these systems exist and how effectively they are implemented.

FDA: The only really new requirement is for representatives to leave a receipt for the samples when they distribute samples to licensed practitioners. That requirement formerly applied only to samples distributed by mail or common carrier.

FDA: Manufacturers or authorized distributors are responsible for ensuring that periodic audits of their sample distribution systems, including the annual inventories on each sales representative, are done by independent personnel. "Independent personnel," in this instance, means personnel that are outside the marketing, sales or promotion functions of the firm.

FDA: In order to ensure that I am answering the right question, let me clarify the difference between the "inventory" and "audit" requirements of the PDMA regulations.

The inventory requirement can be found under section 203.31(d) of the regulations. The inventory must be performed at least annually on all sales representatives, it must include a physical count of all sample stock in the representative's possession and the representative and his or her management may participate in the inventory process.

The audit requirement, described under section 203.34 of the regulations, must be designed to detect falsified or incomplete sample distribution records, and should include provisions for at least two types of audit processes, random and "for cause." Random audits should be conducted on all representatives within a specified time period. "For cause" audits should be triggered in response to reports, incidents or findings identified by the firm as indicating the possible diversion of drug samples or the falsification of records concerning sample distribution. Neither sales representatives nor their supervisors may perform the audit. The audit must be performed by personnel other than the representatives, supervisors or managers in their department, division or branch, or in their direct line of supervision or command.

FDA: We have not, and may decide not to, provide a specific time frame within which a firm must conduct an audit on all sales personnel. Any time frame selected by a firm should be reasonable and based upon such considerations as the number of sales representatives employed by a firm, the volume of sampling activity and how accurately and completely a firm is able to determine the current status of a sales representative's sample inventory and distribution record.

"For cause" audits must, of course, be initiated immediately upon the firm becoming aware of an exception report concerning a sales representative's sampling activities.

FDA: The answer to this question really depends upon the requirements of the sample security and audit system that his or her employer implements.

FDA: That depends upon the results of the misreported data and whether the misreporting was an accident, an error or otherwise. Manufacturers or authorized distributors are responsible for ensuring that their representatives, including contract representatives, comply with the sample distribution requirements of the PDMA.

FDA: Pharmacies of hospitals or other healthcare entities may receive, store and dispense prescription drug samples for affiliated licensed practitioners. Retail pharmacies may not.

FDA: No. The sale of prescription drug samples was one of the primary motivations for Congress to create the PDMA.

FDA: Congressional hearings that led up to the PDMA found that prescription drug samples were being collected from physicians, shucked from their packaging and sold to pharmacists for resale to consumers. Shucking of samples from their original packaging results in complete loss of traceability of the drug in case of recall and, without the expiration date on the drug's packaging, neither the healthcare professional nor the consumer can determine how long the product is safe and effective for use. Storage conditions of the samples were unknown or, in some cases, the drugs were exposed to extremely high temperatures, moisture and/or excessive light. Sample units marked as "SAMPLES" had these markings removed by use of acetone (nail polish remover) or, in cases where the mark is engraved or embossed on the unit, ground out by a file or other abrasive device. All of these conditions would negatively impact the drug's safety and effectiveness for the American consumer.

FDA: Donation of prescription drug samples is permissible, provided the requirements of section 203.39 are met.

FDA: The PDMA prohibits the sale, trade, purchase or offer to sell, trade or purchase a prescription drug sample by any person. The donation of samples to charitable organizations is generally handled at the corporate level. If a manufacturer or authorized distributor permits a representative to donate drug samples, such activity must comply with the sample distribution and recordkeeping requirements of the regulations.

FDA: Following conviction for prescription drug sample sale, trade, purchase or the offer to sell, trade or purchase, a representative can be imprisoned for not more than 10 years, fined not more than $250,000 or both. Civil money penalties up to $1 million can be assessed to manufacturers or authorized distributors.

FDA: If a representative is unaware of PDMA requirements, both the representative and his or her employer may be liable for civil or criminal penalties. PR

For a PDF file of the new regulations, go to www.access.gpo.gov/su_docs/aces/aces140.html. Check the box marked "1999 Federal Register" and type "prescription drug marketing act" in the "Search Terms" field. Click on "Submit" and download the first item: "fr03de99R Prescription Drug Marketing Act of 1997." For more information on how the new regulations affect sample storage, see the October 2000 issue of Pharmaceutical Representative.