HOUSE BILL REPORT

HB 931

BYRepresentatives Leonard, Padden, Braddock, Day, Hine, Lewis, Appelwick and Sprenkle

Regulating the possession and distribution of legend drug samples.

House Committe on Health Care

Majority Report:     The substitute bill be substituted therefor and the substitute bill do pass.  (9)

     Signed by Representatives Braddock, Chair; Day, Vice Chair; Bristow, Brooks, Bumgarner, Cantwell, Lux, D. Sommers and Sprenkle.

Minority Report:     Do not pass.  (1)

     Signed by Representative Vekich.

House Staff:John Welsh (786-7133)

AS REPORTED BY COMMITTEE ON HEALTH CARE MARCH 5, 1987

BACKGROUND:

For marketing purposes, pharmaceutical manufacturers give sample complimentary prescription drugs to physicians and other prescribers.  There is currently no regulation or control over the distribution of these samples and there have been occasions when these drugs have been diverted for other purposes.  Manufacturers' representatives who distribute sample controlled substances are exempt by law from registration by the Board of Pharmacy.

SUMMARY:

SUBSTITUTE BILL:  Pharmaceutical manufacturers that intend to distribute complimentary prescription drug samples must register annually with the Board of Pharmacy.  They must also provide a 24-hour phone number for responding to reasonable inquiries of the board, based on reasonable cause, of possible violations of the law.  Board requests for the location of drug storage sites in this regard must be responded to as soon as possible but no later than the board's close of business on the day following the request.  Records and an inventory of drug samples must be maintained by manufacturers distributing drug samples, available for inspection upon reasonable cause, and any loss or theft of drug samples must be reported as soon as possible.  Manufacturers are required to identify the practitioners to whom the sample drugs are distributed, as well as the drugs.  Requirements for storage, transportation and disposal of drug samples are specified.  Manufacturers are held liable for the acts of their representatives.  A civil penalty of up to $5,000 for violations of the law are provided for, as well as the seizure of sample drugs, after notice and a reasonable opportunity to comply is given by the board.  All records and reports are exempt from public disclosure except the identity of persons violating federal and state laws.

SUBSTITUTE BILL COMPARED TO ORIGINAL:  The board must have reasonable cause in order to make inquiries of manufacturers of possible violations of the chapter and for inspecting records, but it need not make a prior showing of that cause in order to take action.  Technical changes are made.  Drug samples can be distributed only to prescribing practitioners, not dispensers.  Surplus, damaged or outdated controlled substances must be returned to the manufacturer in accordance with board rules and federal law.

Fiscal Note:    Attached.

House Committee ‑ Testified For:     Representative Sprenkle, prime sponsor; Cliff Webster, Pharmaceutical Manufacturer's Association; Jerry Farley, Pfizer Pharmaceutical and Mike Ryherd, Washington State Medical Association.

House Committee - Testified Against: Don Williams, Board of Pharmacy and Lars Hennum, Washington Pharmacy Association.

House Committee - Testimony For:     There is currently no regulation of the practice of distributing free drug samples by manufacturers' representatives.  This bill is a compromise arrived at by the Board of Pharmacy and drug manufacturers.  Regulation is necessary to prevent the illegal and improper diversion of these drugs to others.  This is the single greatest source of drug diversion in terms of volume in the country.

House Committee - Testimony Against: The bill does not contain strong enough authority for the board to act expeditiously.  The board should not have to show reasonable cause to possible infractors of the law before it can act, nor should they necessarily have a prior opportunity to correct a violation before a sanction can be imposed.