FDA is proposing a multifaceted approach to halt the spread of counterfeit drugs and biologics in the United States. The agency
supports establishing an electronic tracking system, but its voluntary nature has raised complaints of inadequacy. Meanwhile,
FDA is requiring drug and biologics manufacturers to add linear bar codes to containers and packages destined for hospitals
(see "FDA Requires Bar Codes on Hospital Drugs"). It remains to be seen if an e-tracking plan that can identify legitimate
products can also remove obstacles to broader importation of pharmaceuticals.
The task of implementing these policies will fall to others at FDA, following the shift of Commissioner Mark McClellan to
administrator of the Centers for Medicare and Medicaid Services (CMS) at Health and Human Resources (HHS). Naming a credible
and knowledgeable individual to implement the Medicare prescription drug benefit and quell complaints from seniors before
the November elections is a top priority for the Bush administration. A physician and economist, McClellan knows a lot about
drug pricing and reimbursement and their impact on biomedical innovation. He analyzed health policy for the White House as
a member of the Council of Economic Advisors before coming to FDA in late 2002, and he advised the administration on provisions
of the Medicare bill.
In reassigning McClellan to CMS, the administration calculated that FDA could weather the change. Deputy commissioner Lester
Crawford served as acting commissioner before McClellan's arrival, a period that witnessed the launch of FDA initiatives to
modernize good manufacturing practices (GMPs) and to consolidate regulation of biotech therapies with drugs. Recently he has
been heading up food and animal safety and antibioterrorism initiatives, prime HHS concerns.
Last fall, McClellan moved Janet Woodcock, director of CDER, to the Office of the Commissioner (OC) to help implement many
of his risk management and strategic plan initiatives. Now Crawford has asked Woodcock to remain as one of three acting deputies
instead of returning to CDER in April as planned. Woodcock will be deputy for operations, Murray Lumpkin deputy for special
programs, and Amit Sachdev deputy for policy. Woodcock says she can extend her OC stay because CDER is in good hands under acting director Steven Galson. Galson's main
priorities are to continue integrating biologics staffers into CDER and to plan for the Center's move to new offices next
year. Woodcock remains in charge of GMP modernization, developing guidance on protein characterization, and crafting a policy
for generic, or follow-on, biologics, which is expected this spring.
No Magic Anticounterfeit Bullet
The centerpiece of FDA's report on "Combating Counterfeit Drugs" is encouraging manufacturers, distributors, and pharmacists
to adopt a new "track and trace" system for drugs and biologics. This involves inserting radiofrequency identification (RFID)
chips into drug packages and labels that will track product movements from plant to pharmacist and ultimately to the patient.
In addition to thwarting illegal operators, the e-tracking system could improve inventory control programs for all parties
and help recall products with safety problems.
FDA side-stepped some of the more controversial issues that arose at its October 2003 open meeting on anticounterfeiting.
The agency is not requiring manufacturers to put finished dosages in unit-of-use packaging because such a change would be
costly and would not control counterfeiting significantly. For now, FDA is encouraging manufacturers to analyze the costs
and benefits of unit-of-use packaging, starting with newly approved drugs, injectables, and products most likely to be counterfeited.
Similarly, FDA is not mandating use of any specific antitampering packaging or product authentication systems, such as holograms,
colored labels, or chemical markers. Such approaches may help prevent counterfeiting, but FDA believes there is no one "magic
bullet" to foil illegal operators. Moreover, recommending any one authentication technology might alert counterfeiters to
industry practices and also stifle further innovation. Manufacturers, instead, should explore the range of anticounterfeiting
technologies and determine which fit best with specific products and dosage forms as well as company capabilities. Meanwhile,
FDA will develop guidance on how companies can adopt anticounterfeit packaging and labeling for approved products without
obtaining prior approval for these changes.
