The Honorable J. Dennis Hastert
235 Cannon House Office Building
U.S. House of Representatives
Washington DC 20510
Dear Speaker Hastert:
On behalf of the 1,000 members of the Biotechnology Industry Organization (BIO), I would like to convey our very strong concern and objection to H.R. 2427, the Pharmaceutical Market Access Act of 2003, which would significantly weaken regulation on the importation of prescription drugs and subject Americans to a potentially unsafe drug supply. Today, American citizens have absolutely the safest supply of medicines in the world. We cannot afford to risk that safety by enacting H.R. 2427. We understand the bill may be considered by the House in the near future, and we urge you to vote against it.
H.R. 2427 will put in place requirements that all new products include so-called "anti-tampering" packaging and "anti-counterfeit" technology. This requirement would immediately restrict access to much-needed drugs and biologics as few, if any manufacturers are equipped to retrofit operations to meet this mandate. Furthermore, the premise for these requirements is that such technology will prevent the worst cases of counterfeiting and contamination. But such technology, where it even exists, is brand new and has no track record as a viable approach to ensure the safety of drug products. Even technology already in common use in the industry, such as holography, is definitely not foolproof. In fact, companies find they must change holograms many times a year, as counterfeiters are very adept at duplicating them quickly.
There are also enormous technical problems with the anti-counterfeiting packaging provisions. For example, they can be read as applying on the date of enactment, thus rendering biotech products "misbranded" and subject to immediate removal from the market. This is complicated by the fact that, currently, changes to packaging can require pre-approval by the U.S. Food and Drug Administration (FDA). Moreover, it is difficult to reconcile the provision with current requirements for changes to the packaging of drugs (other than tablets and capsules) that come into contact with the drug substance. Currently, in the case of changes involving a pre-filled syringe or vial, manufacturers must carefully assess, and probably study, whether it must submit an additional application to FDA for review and approval. Preparing these types of applications can take substantial time and effort, and agency review likewise can span months, if not years.
Furthermore, H.R. 2427 offers no guarantees that wholesale importers pass savings on to American consumers. In fact, the anti-counterfeiting measures in H.R. 2427 will have the exact opposite effect. Complying with the mandated anti-counterfeiting measures will undoubtedly result in product pricing increases if manufacturers are required to submit FDA supplemental applications and retrofit labels. H.R. 2427 simply casts an illusion of safety, while stripping American consumers any assurances of protection and savings.
Over the past several years, both the House and the Senate have passed legislation putting in place requirements for the regulation of "reimported" and imported drug products. These provisions are in the law today, subject to the caveat that before allowing such importation, the Secretary of Health and Human Services (HHS) must certify that the products are safe and that consumers will, in fact, receive the benefit of cost savings on the products. Secretary Tommy Thompson, like his predecessor Donna Shalala, has said he cannot make such a certification to Congress; both Thompson and Shalala have emphatically informed Congress that FDA cannot ensure the safety of such products, and that because nothing in the statute would require the importer to pass along any savings to consumers, no such savings can be assured. Nevertheless, H.R. 2427 eliminates such safety and cost savings certification, surely a dangerous change for consumers.
At multiple hearings before several committees of the House and Senate, officials of both the FDA and HHS have testified that lowering standards for "reimported" or imported drug products undermines and threatens the gold-standard regulatory system on which American consumers rely. There is clear and convincing evidence of products ordered and obtained from non-U.S. sources that contain no active ingredient or a dangerous excess of active ingredient, or are contaminated, misbranded, out-of-date, or frank counterfeits. In the end, consumers cannot ascertain these product flaws, which only can be demonstrated by complex laboratory analysis.
To illustrate, in May 2002 the FDA determined a lot of Serostim®, a growth hormone product of Serono Laboratories used to treat patients afflicted with HIV/AIDS, contained no active ingredient and did not originate from Serono. Similarly, in the spring of 2002, Amgen, Inc. became aware of a potential counterfeit of its product, Epogen®, which is used in the treatment of anemia associated with chronic renal failure for patients on dialysis. Highly sophisticated counterfeiters replicated the Epogen vial, label, physician directions, and optical carton closure system. The forgeries can only be identified through detailed scrutiny of each individual vial and complex laboratory analysis. In fact, after extensive laboratory analysis, tests concluded the vials contained only a clear liquid with approximately one-twentieth the level of active ingredient indicated on the label.
Further, most biotech products are biologic agents and are therefore highly dependent - for both their effectiveness and their safety - on the conditions and temperatures in which they are stored and on how they are handled both during distribution and after they reach their destination. The examples cited were especially susceptible to contamination and their alteration or counterfeiting was impossible to detect. Even with an exemption for biologics, unscrupulous actors can and will attempt to subvert the existing ban through the elimination of the Secretary's safety certifications contained in current law. Because biologics are typically injected into the bloodstream, the risk to patients from such illegally imported products, prepared or handled incorrectly, is immediate and incalculable.
Counterfeiting is not unique to biologics; many chemically synthesized drugs have been subjected to counterfeiting. For example, Pfizer Inc. recently had a similar situation when counterfeit drug tablets identified as Lipitor© were sold in packages prepared by Med-Pro, a pharmaceutical repackaging company based in Lexington, Kentucky with no relationship to Pfizer Inc. Pfizer became aware of the counterfeit Lipitor when patients and pharmacists described an unusually bitter taste. Tablets from Med-Pro packages purporting to contain Lipitor 10mg and 20mg bear a close resemblance to authentic Lipitor.
The argument that the provisions of H.R. 2427 are necessary to make medicines more affordable is tenuous at best; as there is absolutely no evidence that wholesale reimportation/importation will result in cost savings to consumers. Counterfeiters exist, and H.R. 2427 would eliminate the patient safety requirements and give false hope that these counterfeit measures will provide the needed protection. Thus, we stand to place American patients at risk with no commensurate benefit. BIO implores you to vote against H.R. 2427, the Pharmaceutical Market Access Act of 2003.
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states. BIO members are involved in the research and development of health care, agricultural, industrial and environmental biotechnology products. For more information, please contact Sharon L. Cohen, vice president for Government Relations, at (202) 962-9200 or firstname.lastname@example.org.
Carl B. Feldbaum
Biotechnology Industry Organization