The Honorable Mark B. McClellan
United States Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Re: Personal Importation of Biological Products
Dear Dr. McClellan:
The Biotechnology Industry Organization (BIO) writes about a serious public health threat - the increasing popularity of importing drugs and biological products for personal use. This practice takes several forms - Internet purchases of drugs from on-line "pharmacies," personal importation of drugs through U.S. ports of entry, and the shipment of drugs from foreign sources through the mails. All of these pose serious risks to patients, especially when biological products are involved.
BIO represents the broad spectrum of biotechnology companies, providing information, advocacy, and business support to the biotechnology industry. As such, our members are extremely concerned about this growing practice. To that end, we request that the Food and Drug Administration (FDA) take steps to strengthen its recently-revised import policy to specifically address the hazards posed by illegal importation of unapproved biological products.
The issue of importation of pharmaceutical products for personal use has received increasing attention in recent years. Many have advocated policies to allow consumers to bring regulated drug products into the United States from foreign countries where prices might be lower. To that end, FDA has exercised its enforcement discretion and allowed personal importation under clearly defined, limited circumstances. See FDA, Regulatory Procedures Manual, Chapter 9, Subchapter: Coverage of Personal Importations. Under that policy, FDA employees working with U.S. Customs Service border agents may release unapproved drugs into the United States for personal use if "the drug is intended for a serious condition for which effective treatment may not be available domestically . . . and [such use] is not considered to represent an unreasonable risk." Id. The agency has always made clear, however, that its policy "does not provide anyone with a right to import any drug." Id.
In an effort to expand this policy, several members of Congress introduced legislation during the last congressional session to allow increased importation of drugs and biological products. One such effort attempted to relax the current restrictions on the wholesale re-importation of drugs and allow the personal importation of prescription drugs from Canadian pharmacies. See The Prescription Drug Price Parity for Americans Act (S.2244). Wisely, the agency took the position that, were they enacted, it could not safely implement the legislation's provisions. See Letter from Lester M. Crawford, Deputy Commissioner, FDA, to the Honorable Thad Cochran, July 17, 2002.
As you know, two Secretaries of Health and Human Services have informed Congress that the Medicine Equity and Drug Safety Act (the MEDS Act) could increase public health risks and therefore could not be implemented under the terms of that statute. See, e.g., Letter from Tommy G. Thompson, Secretary, Dept. HHS, to the Honorable James Jeffords, July 9, 2001. The MEDS Act, like S. 2244, promised to substantially broaden provisions governing the re-importation of drugs by allowing pharmacists and wholesalers to engage in re-importation. 1/ Such expansion, Secretary Thompson argued, would expose American consumers to a greater risk of counterfeit, superpotent, subpotent, contaminated, and inappropriate products. Id.
The logic of FDA's position is clear. As the Senior Associate Commissioner for Policy, Planning, and Legislation stated during a congressional hearing in July 2002:
importing prescription drugs for personal use is a potentially dangerous practice. FDA and the public have no assurance that unapproved products are effective or safe, or have been produced under U.S. goods manufacturing practices. FDA cannot assure the public that re-imported drugs made in the U.S. have been stored under proper conditions or that they are even the real product, because the Agency does not regulate foreign distributors or pharmacies. Therefore, unapproved drugs and re-imported approved medications may be contaminated, subpotent, superpotent, or counterfeit.
Statement of William K. Hubbard before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives, July 25 2002.
BIO wholeheartedly agrees with Senior Associate Commissioner Hubbard's statement and with the agency's recent efforts to identify dangerous drugs as ineligible for personal importation before unsuspecting consumers attempt their re-importation.
FDA's December 2002 Import Alert
On December 9, 2002, the agency announced the revision of an Import Alert to strengthen the controls designed to protect patients by restricting the importation of certain approved prescription drugs. See FDA Strengthens Controls, Issues Consumer Alert, FDA News, Dec. 9, 2002; IA#66-41 - 9/28/00 Revision of Import Alert #66-41 "Unapproved New Drugs Promoted in the U.S." Attachment Revised 12/6/02 (Import Alert). Under the Alert, FDA may detain drugs offered for importation without conducting a physical examination to determine whether they meet the agency's permissive importation enforcement policy. On December 6, 2002, FDA added 10 products, including four biological products, to the list of products subject to immediate detention. /2 As a result, these drugs are not eligible for personal importation.
FDA Should Further Tighten its Personal Importation Policy
BIO commends the agency for taking this necessary step to protect consumers from unapproved, and potentially dangerous, drugs. As part of this effort, BIO encourages you to pay special attention to biological product safety, as biological products are especially vulnerable to each and every locus of concern FDA has identified for drug products. Indeed, all of FDA's concerns about personal importation are implicated when consumers import or re-import biological products.
For example, biological products, particularly those manufactured through biotechnology processes, are especially subject to counterfeiting. The agency must be vigilant in its efforts to restrict consumers' access to counterfeited biological products - whether they are counterfeited in the United States or abroad.
Additionally, biological products are particularly sensitive to "inappropriate and unsafe conditions." Many therapeutic biologics are complex products, derived from human or animal cells that are genetically altered to produce a certain protein structure. In general, such products are difficult to characterize and, because of their complexity, are defined primarily by careful control of source materials and processes. Because biologics are so difficult to characterize by analytic methods, they are not amenable to screening for authenticity or integrity. And, because most therapeutic proteins are cultured and manufactured from living cells, they are more susceptible to contamination and much more likely than most drug products to lead to the introduction of adventitious agents. So simple a mishandling as improper temperature control, on foreign soil, by persons not subject to FDA oversight, at sites not subject to FDA oversight, can easily render a biological product not merely ineffective but dangerous. These concerns apply whether the product is imported by a consumer returning to the U.S. from another country or is sent through the mails or by courier following purchase on the Internet. In either case, the safety, efficacy and quality of the product could be degraded due to inappropriate transportation, storage and handling.
For all these reasons, BIO both applauds FDA's efforts to protect the public against unsafe imports and urges further safeguards against unsafe, imported biological products. BIO looks forward to working with FDA to develop and implement such safeguards.
Carl B. Feldbaum,
Biotechnology Industry Organization
1/ Under current law, only manufacturers of drug products may lawfully re-import those products to the United States. 21 USC 381.
2/ They are 1) Accutane (isotretinoin), (2) Actiq (fentanyl citrate), (3) Clorazil (clozapine), (4) Lotronex (alosetron hydrochloride), (5) Mifiprex (mifepristone or RU-486), (6) Thalomid (thalidomide), (7) Tikosyn (dofetilide), (8) Tracleer (bosentan), (9) Trovan (trovafloxacin mesylate or alatrofloxacin mesylate injection), (10) Xyrem (sodium oxybate).