Pfizer's cholesterol-lowering drug Lipitor could be one of the first additions to a list of 30 drugs with new "pedigree" paper requirements in Florida.

Under the ¹ 'Prescription Drug Protection Act' signed by Gov. Jeb Bush (R) June 13, Florida will begin enforcing pedigree requirements Sept. 1 for 30 types of drugs that have been counterfeited or adulterated in the past.

Among the 30 products on the list of drugs that need pedigrees are Amgen's Epogen and Neupogen , J&J's Procrit and Merck's Zocor . The list does not include either Lipitor or Pfizer's erectile dysfunction agent Viagra - two products that have increasingly become the target of counterfeiters.

For instance, Albers Medical Distributors has recalled all lots of Lipitor that were repackaged by Lexington, Neb.-based Med-Pro due to potential counterfeiting (² 'The Pink Sheet' June 2, 2003, In Brief).

Under the Florida law, a new Drug Wholesaler Advisory Council will make recommendations about which products should be added to the current list of 30 specified drugs.

"There are a couple more drugs that I know just off the top of my head that should probably be added to the list, probably Lipitor. Viagra's not on the list," Florida Department of Health Bureau of Statewide Pharmaceutical Services Compliance Manager Sandra Stovall said at a recent Healthcare Distribution Management Association conference in Orlando, Fla.

The council will comprise 11 members, including representatives from three primary distributors that operate nationally and two representatives from the state DoH. Secondary distributors, retail pharmacies, the state Board of Pharmacy, physicians, hospital pharmacies and manufacturers will have one representative each on the council.

"This drug advisory council is going to provide assistance to the department," Stovall said. "There are criteria set forth in the law that will help guide the advisory committee and the department to add [new drugs] to the list."

After drugs are added to the list, pedigree requirements will take effect in 60 days.

However, the law also contains provisions for emergency additions to the list.

Within seven days of a drug's addition to the list under the emergency rule, "you need to go through your inventory and make a list of all the drugs, all the stock that you have of that particular drug, notify the department," Stovall said. "And then when you distribute that drug, you'll provide to your customer a statement that that product was on hand before the drug was added to the specified list."

Under the new pedigree requirements for the 30 specified drugs, an authorized distributor of record must provide to a purchasing wholesaler a written statement indicating that each unit of a specified drug was purchased from the manufacturer. Non-authorized distributors of record must provide a full pedigree for products on the specified list.

"What this means is if you have product inventory in stock now, you need to start working through, getting that sold, moved, whatever, so that the stock that you have on hand on Sept. 1 you have the pedigree that you need, or whatever documentation you need, so that you can comply if you distribute any of these specified drugs to another wholesale distributor," Stovall said.

Under the law, a new, narrower definition of authorized distributor of record takes effect March 1, 2004. Under the new definition, a distributor must meet one of three qualifications to be an ADR, HDMA State Legislative Affairs Director David Kosar said.

A distributor must be on the manufacturer's list of ADRs. If not on the list, a distributor must either have purchased 90% of the manufacturer's product directly from the manufacturer and had sales of $100 mil. or more annually, or reported to DoH annual sales exceeding $100 mil., have a verifiable account number issued by a manufacturer and make a minimum of 12 purchases in 12 months, Kosar explained.

Pedigrees must be passed on for specified drugs only to distributors until July 1, 2006. At that time, "it is full pedigree on every product that is sold and distributed, and pedigree will be passed down to pharmacy customers and pedigree will trace back to the manufacturer," Kosar pointed out.

"I think the hope is by July 1, 2006, there will be adequate automation to facilitate the pedigree paper tracking the drug through the system," Stovall said.

The new law also imposes due diligence requirements on purchasing distributors to authenticate prior transactions on pedigree papers. In addition, the law strengthens permitting requirements for wholesalers, including higher bonding requirements and stricter background checks, and creates new felony crimes for obtaining or selling drugs without a proven history or pedigree.

The new requirements resulted from an ad hoc working group of government and industry representatives aimed at strengthening measures against drug counterfeiting. In addition, a state grand jury in February called for new legislation requiring wholesalers and repackagers to verify the contents of pedigree papers (³ Also see "Wholesaler Arguments Against Rx Pedigree Papers “Weak” – Fla. Grand Jury" - Pink Sheet, 17 March, 2003., p. 26).

FDA issued its final pedigree rule, as required under the Prescription Drug Marketing Act, in 1999, but has repeatedly delayed implementation due in part to opposition from the wholesaler industry.

The agency currently is delaying implementation until April 2004 to give Congress time to determine whether an amendment to the PDMA, which exempts authorized distributors from maintaining and passing on prescription drug pedigrees, is appropriate.

The drug wholesaler and manufacturing industries are boosting their efforts to tackle counterfeiting.

On June 24, HDMA announced a new program, effective July 1, under which member companies pledge to notify FDA's Office of Criminal Investigations and the drug manufacturer within five working days of discovering a suspicious product. "The program goes beyond our nation's borders, and includes counterfeit drugs that could be brought in the U.S. from foreign countries," HDMA said.

The Pharmaceutical Research & Manufacturers of America instituted a similar program in May (⁴ 'The Pink Sheet' April 28, 2002, In Brief).

Drug reimportation and counterfeiting issues continue to provoke heated debate on Capitol Hill, with two House subcommittees holding hearings the week of June 23 (see ⁵ Also see "Pharmachemie Cisplatin ANDA Should Get 180-Day Exclusivity As First To File" - Pink Sheet, 28 June, 1999. ).

Florida Pedigree Enforcement For 30 “Specified” Drugs Begins Sept. 1

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