FDA Steps Up Campaign Against Rx Imports; Bill “Technically” Flawed

Pending federal legislation to allow importation of prescription drugs from Canada would create unworkable conflicts with state pharmacy laws, FDA Commissioner Mark McClellan told the National Association of Boards of Pharmacy legislative conference Sept. 14 in Washington, D.C.

"The bills are, quite simply, contradictory," McClellan declared. "As written, I don't think they would technically allow any drugs to enter."

"All the bills would create a conflict with the pharmacy laws of every state since these prescriptions would be written by people who are not licensed to prescribe in the state under circumstances that do not meet the legal definition of a prescription in the state," McClellan said.

The House and Senate Medicare bills include provisions intended to open up the border to allow importation of cheaper versions of drugs approved in the U.S. The House affirmed its support for reimportation by a broad majority in a follow-up bill (¹ (Also see "Rx Reimportation Passes House; CBO Score May Keep It Out Of Medicare Rx" - Pink Sheet, 28 Jul, 2003.), p. 13).

McClellan maintained that there is an inherent contradiction in the import bill, because it bypasses the agency's regulatory authority while still mandating that drugs meet standards set by the FD&C Act.

"The bills say that the drugs that should be allowed in are ones that comply with Sections 501, 502, and 505 of the Food, Drug and Cosmetic Act - the nation's core drug safety law," McClellan said.

"In order to comply with these provisions, the imported drugs would have to meet the conditions that are currently required for legal imported drugs - not surprising, since those are the conditions required for FDA approval and for assuring safety," the commissioner added.

Some lawmakers in Congress are discussing the possibility that passing a drug reimportation bill could be a backup plan if the Medicare conference committee fails to pass a full prescription drug benefit for seniors.

McClellan maintained that current packaging technologies are inadequate to guarantee the safety of imported products. Importers "rely on one or a few unproven technologies on the drug package system to substitute for a comprehensive system for assuring safety - an approach that in modern times simply cannot provide reliable assurance that the drugs in the package are legitimate and safe."

"An imprint on a box is no substitute for a comprehensive, multi-part system for assuring drug safety from production to patient," said McClellan.

The FDA commissioner commented specifically on AARP's support for reimportation. The seniors association has endorsed reimportation to put "downward pressure" on drug prices (² (Also see "AARP Supports Canadian Imports To Place “Downward Pressure” On Rx Costs" - Pink Sheet, 11 Aug, 2003.), p. 20).

"AARP has made some good points recently," McClellan said. "AARP pointed out that the way drugs are priced around the world is unfair to millions of Americans, and that something should be done about it."

"They also correctly pointed out that, in order to keep the drug supply safe, any legislation to allow importation is going to require significantly more resources and more authorities at FDA, to assure drug safety and integrity of our drug supply with a broader range of drug products," he continued.

"It is worth noting that none of the drug importation bills that have been proposed do this."

FDA is also stepping up its efforts to dissuade state and local governments from authorizing or engaging in reimportation.

McClellan suggested that local governments need to consider the costs associated with running a safe import program.

The necessary apparatus to monitor drugs would be costly and would likely offset some of the savings that state and local governments had hoped to obtain by purchasing cheaper reimported drugs from Canada, the commissioner said.

"For something as serious as prescription drugs, they would need to monitor the sources and distribution of the drugs involved and make sure they were manufactured reliably and distributed safely," McClellan said. "They would need to inspect and test the drugs, to make sure they are legitimate products."

"They would need to get help from the Canadian government or its provinces, to make sure that the prescriptions filled outside the U.S. are legitimate and are filled legally under Canadian law, and the drugs themselves are genuine and are transported, labeled, and used according to appropriate safety and risk management standards."

"If they don't, they are likely to run into the same safety problems faced by everyone else attempting to import unapproved illegal drugs," McClellan said, including receiving drugs that are improperly stored, shipped or dispensed. Imported drugs "may be ineffective or harmful for many other reasons."

FDA spelled out its concerns with state-sponsored importation programs in an Aug. 25 letter to the California Attorney General (³ (Also see "Public Sector Reimportation Programs Violate FD&C Act, FDA Tells Calif." - Pink Sheet, 1 Sep, 2003.), p. 9).

FDA underscored those concerns during a meeting with the mayor of Springfield, Mass. on Sept. 16. FDA Chief Counsel Dan Troy, Associate Commissioner for External Affairs Peter Pitts, Senior Associate Commissioner for Policy & Planning William Hubbard, and Associate Commissioner for Regulatory Affairs John Taylor participated in the meeting.

Springfield hopes to save from $4 mil.-$9 mil. annually by encouraging its 9,000 current and retired employees to purchase Canadian imported drugs from third party Internet services. The city plan, which began July 8, waives the co-pay for these drugs, which is currently set at $5-$10 for U.S. pharmacy prescriptions. The co-payments will increase to $10-$35, effective Oct. 1.

FDA issued a warning letter to Springfield's importer, CanaRx, on the same day as the meeting.

"Your actions violate the FD&C Act," the warning letter declares. "Your actions also present a significant risk to public health, and you misled the public about the safety of the drugs obtained through CanaRx Services, Inc."

"An FDA investigator that filled prescriptions through your company ordered and received insulin, a product that should generally be stored under refrigerated conditions," the letter states. "But the product was not shipped in a manner that ensures adherence with storage conditions specified in FDA approved labeling, potentially compromising its safety and effectiveness."

FDA also cautioned the company that if it fails to respond to the FDA's warning letter, further actions will be taken against the company. "Possible legal actions include seizure and/or injunction," FDA warned CanaRx. The agency has initiated an injunction against another internet importer, Rx Depot (⁴ (Also see "FDA Import Crackdown Escalates With DoJ Suit Vs. Canadian Pharmacy Site" - Pink Sheet, 15 Sep, 2003.), p. 5).

FDA took another well-timed enforcement action Sept. 15, announcing the seizure of products held by Alliance Wholesale Distributors and Local Repack, Inc. of Richton Park, Ill.

The seizure action was filed against "all drug products labeled in a foreign language and/or labeled as repacked by Alliance Wholesale Distributors and/or Local Repack, Inc." The agency described the products as "of unknown origin, and their storage and handling is unverifiable."

The seizure action came the same day Illinois Gov. Rod Blagojevich (D) asked state officials to investigate allowing state employees and retirees to import drugs from Canada.

"The skyrocketing cost of prescription medications is a huge burden for consumers and for taxpayers who help pay for state employee's health costs," Blagojevich said. "Anything we can do that safely and effectively reduces those costs is definitely worth looking into."

In response to Illinois' plan to import drugs from Canada, NABP requested a meeting with Blagojevich to discuss its safety concerns. "Access to medications is certainly an important issue to U.S. citizens and Illinois citizens, but endangering the citizens of Illinois is the serious concern that we have," NABP said.

The American Pharmacists Association echoed NABP's concerns. "The Illinois action is setting a short-sighted and dangerous precedent. Why would we place our fellow citizens at risk when there are other ways to lower medication costs?" APhA asked.

McClellan praised state pharmacy boards for working with FDA to attempt to prevent illegal drug importation. "Thank you for what you have done to try to keep the drug supply safe there. We do need to all be vigilant about these kinds of new challenges to drug safety in the U.S.," McClellan told NABP.