CBER Counterfeit Procedures Stress Need For Improved Communication

The Center for Biologics Evaluation & Research's standard procedures for responding to a counterfeit product event emphasizes the need for more efficient communication between FDA and outside parties.

CBER's Manual of Standard Operating Procedures and Policies "Procedures For Responding to a Counterfeit Product Event" outlines a process for center staff to follow up on a report of potential counterfeit products.

"This procedure provides the framework for more efficient communication within the Center and between appropriate FDA staff and those participants outside the agency," the March 9 ¹ SOPP says.

CBER issued the operating procedures in response to an increase in counterfeit biologics over the last several years.

"As the manufacturing and distribution system has become more global in nature, protecting against counterfeit products becomes more challenging," the SOPP says.

"FDA continues to believe that the quality of products in this country is high, and that the public can continue to have confidence that the products sold in the U.S. market are authentic. The agency, however, takes very seriously any allegations or information regarding the counterfeiting of products."

One biologic with a recurring counterfeit problem is Johnson & Johnson's Procrit (epoetin alfa). J&J and FDA warned of contaminated product in March 2003, and issued similar letters in June 2002 and October 2002 (² (Also see "J&J Procrit Counterfeits Return: Contaminated Product Found In Florida" - Pink Sheet, 17 Mar, 2003.), p. 25).

J&J has taken a number of steps to prevent counterfeits and most recently began requiring wholesalers to buy the anemia therapy directly from the manufacturer (³ , p. 37).

Counterfeits have taken on an even greater prominence lately given the increased attention to reimportation. Opponents of reimportation have argued there is a greater likelihood for counterfeiting should the U.S. open its borders.

FDA has repeatedly questioned the safety of reimportation and is advocating "track and trace" radio frequency identification to better secure the drug supply chain. Certain drugs at high risk of being counterfeited are expected to bear RFID tags in late 2005 (⁴ (Also see "FDA Anticounterfeit Carrot & Stick: Radio Frequency I.D., No Paper Pedigree" - Pink Sheet, 23 Feb, 2004.), p. 14).

FDA considered using paper pedigrees to combat counterfeits but decided to delay the effective date of the requirement to allow for the switch to RFID technology.

Under CBER's operating procedures, the Office of Compliance and Biologics Quality (OCBQ) serves as the "focal point" on counterfeit product investigations.

Upon receipt of a report of a potential counterfeit product, OCBQ "immediately schedules" an internal meeting with the OCBQ director and deputy director, the Division of Case Management director and the assistant to the director of policy.

During or immediately following the meeting, the appropriate parties are notified: the manufacturer, product office, Office of Regulatory Affairs, Office of Criminal Investigations, Office of Biostatistics and Epidemiology and FDA communications.

OCBQ forms an ad hoc internal response team that includes officials from ORA, OBE, the appropriate product office and the FDA communications office.

OCBQ takes the lead in developing an initial action plan and contacts the manufacturer for information on the potential counterfeit incident. Other members of the ad hoc team may participate in communications with the manufacturer as appropriate.

After an action plan is drawn up, OCBQ and the communications office coordinate with the manufacturer to post information on FDA's website. The communications office also develops a "Q&A."

OCBQ consults with the manufacturer about necessary tests and discusses relevant public health and safety issues. OCBQ communicates the information to the Office of Criminal Investigations as needed.

Finally, OCBQ tracks and interprets the information provided to FDA, including any adverse event reports, and updates senior CBER management on the progress of the investigation, as necessary.