An FDA task force could look to Florida's new drug wholesaler licensing requirements as a model that all states should adopt to combat counterfeiting.

Florida's approach is "an example of the kind of thing that we'll be pursuing in the task force as potentially part of a model act that we could recommend for states to adopt more widely," FDA Commissioner McClellan said during a July 16 press call unveiling the agency's "¹ Counterfeit Drug Initiative."

"We'll be looking at best practices from states like Florida and elsewhere to see if we can come up with the best possible suggestions for states in regulating wholesalers," McClellan said.

Florida's "Prescription Drug Protection Act," signed into law in June, strengthens wholesaler permitting requirements and requires purchasing distributors to exercise due diligence in authenticating prior transactions on pedigrees (² Also see "Florida Pedigree Enforcement For 30 “Specified” Drugs Begins Sept. 1" - Pink Sheet, 30 June, 2003., p. 27).

Under the law, the state will begin enforcing "pedigree" paper requirements Sept. 1 for 30 types of drugs that have been counterfeited in the past. Full pedigree requirements for all drugs take effect in July 2006.

The task force is "certainly going to consider" recommending that other states take steps to tighten up wholesaler licensing requirements, Associate Commissioner for Regulatory Affairs John Taylor said.

The task force will "identify mechanisms to strengthen the wholesale distribution system, such as helping create a model code of conduct for wholesalers and strengthen the model practice act for wholesale distributors for states to adopt," FDA said in a ³ background paper on the initiative.

In the late 1980s, many states adopted model codes governing wholesale drug issues, Taylor said. "One of the things that we'd like to do in the future is work with the states to determine whether or not those model codes are still applicable in light of the problems we're seeing."

Taylor said steps taken by Florida to tighten wholesaler requirements are "very positive."

"We've already been in discussion with the National Association of Boards of Pharmacy...and they are going to partner with us on the creation" of model practices, FDA Associate Commissioner for Policy & Planning Bill Hubbard said.

FDA's task force also will look at the agency's current plans to implement its final pedigree rule, as required under the Prescription Drug Marketing Act, in April 2004. Implementation has been repeatedly delayed to address concerns raised by wholesalers and to give Congress time to consider whether the law, which exempts authorized distributors from maintaining and passing on pedigrees, should be amended.

Hubbard and Taylor will co-chair the task force, which will submit its initial recommendations to McClellan in approximately 60 days and issue a final report in six months following public comment.

The group will consist of representatives from numerous agency divisions, including the offices of regulatory affairs, enforcement, criminal investigations, policy, external relations and chief counsel, as well as the Center for Drug Evaluation & Research's compliance office.

One of the group's primary objectives will be to examine the use of new technologies to make counterfeiting more difficult.

"Our task force will scrutinize new ways to ensure both the quality and security of the drugs distributed in the U.S. through new technologies, such as radio frequency identification, counterfeit-resistant packaging, chemical taggants and other new weapons that have not been widely used before," McClellan said.

The commissioner cited the need to improve drug tracking technologies in a speech to the National Community Pharmacists Association in May (⁴ Also see "FDA Import Policy Discourages Promotion, Not Reimbursement – McClellan" - Pink Sheet, 26 May, 2003., p. 21).

During a House Government Reform/Human Rights & Wellness Subcommittee hearing in April, Congressional reimportation advocates urged FDA to consider the use of "counterfeit-proof" packaging technologies, including blister packs and color-coded package sealing, to help ensure the safety of drugs imported from Canada (⁵ Also see "Rx Imports: House Cmte. Tells FDA To Consider “Counterfeit-Proof” Packages" - Pink Sheet, 7 April, 2003., p. 14).

However, the agency is not backing down from its stance that reimported drugs pose potential safety risks.

"Wholesalers, pharmacists, consumers and FDA have no way of knowing if any drug reimported into the U.S. is truly the U.S.-approved product or has been inappropriately stored or handled," the agency said in a ⁶ Q&A paper on the counterfeiting task force.

The counterfeiting initiative was announced a week before the House is expected to vote on a stand-alone reimportation measure (see ⁷ Also see "Global Rx Pricing Will Be Focus Of Medicare Rx Conferee Berry" - Pink Sheet, 21 July, 2003. ).

The task force will work with the Bureau of Customs & Border Protection on "blitz" operations at four international mail facilities this summer.

Customs "scientists will work with FDA inspectors to target, examine and test packages containing pharmaceuticals," FDA said. "This operation will enable [Customs] to evaluate the type, volume and quality of imported medications, along with providing reliable and up-to-date data to FDA."

The task force also will examine ways to strengthen current systems for alerting parties in the distribution supply chain about suspected counterfeit products.

Under voluntary programs, member companies of the Pharmaceutical Research & Manufacturers of America and the Healthcare Distribution Management Association currently notify FDA's Office of Criminal Investigations about suspected counterfeit drugs within five working days of discovery of the product.

Taylor said Pfizer notified the agency "very quickly" about counterfeiting of Lipitor . However, the agency does not always release information on a counterfeiting investigation immediately because "we need to...make sure we understand what's in the product, have a better understanding of how wide the product has been distributed," he said.

FDA first released news of the Lipitor counterfeiting in May, and the agency is conducting an "intense, ongoing criminal investigation," McClellan said.

When asked during the press call whether the presence of a counterfeit drug in the marketplace prior to FDA's first release of such information creates a public health issue, McClellan said, "absolutely, and that is why we're setting up this task force to make sure that we're responding quickly and we will make sure if there is a public health threat the message gets out quickly to the public and we're going to find even more effective ways to do that."

Another task force objective will be to examine whether stiffer criminal penalties would deter counterfeiting.

"The current penalty for counterfeiting a drug label is 10 years in prison, but for counterfeiting the actual drug may only be three years in prison," McClellan said.

The commissioner noted the nature of drug counterfeiting has shifted in recent years. "We're seeing more counterfeiting of finished pharmaceuticals," he said. "In the past, more of the counterfeiting involved bulk drug ingredients."

The agency said it intends "to work with Congress to stiffen penalties for those who counterfeit drug products."

Both PhRMA and HDMA issued statements supporting FDA's initiative.

In June, PhRMA announced its own five-point program for combating counterfeiting, which includes holding an anti-counterfeiting summit and creating a PhRMA task force to develop other preventive actions (⁸ Also see "Rx Imports: Package Technology Unable To Guarantee Safety, GSK Says" - Pink Sheet, 16 June, 2003., p. 17).

HDMA said it is broadening the size and scope of its Product Safety Task Force into a group that will look at developing industry best practices for implementing anti-counterfeiting technological solutions.

The expanded group is expected to encompass more than 20 different organizations, including drug manufacturers, distributors, pharmacists, consumers and FDA.

FDA's counterfeiting initiative dovetails with McClellan's heightened focus on the agency's enforcement powers.

In June, FDA released a "White Paper" highlighting its recent enforcement actions, and McClellan is slated to give a speech entitled "Meeting New Threats with Toughened Enforcement Standards" at the National Press Club in Washington, D.C. Aug. 8 (⁹ Also see "FDA Plays Up Police Role; “White Paper” Recaps Recent Enforcement Steps" - Pink Sheet, 7 July, 2003., p. 30).

FDA Counterfeiting Task Force To Look At Tighter Wholesaler Licensing

More from Archive

More from Pink Sheet