In the last several years, the increasing popularity of importing prescription drugs for personal use has created a serious public health threat. Many have advocated policies to allow U.S. consumers to obtain prescription drugs from foreign countries where, they say, prices might be lower. Consumers might obtain foreign products by purchasing from on-line "pharmacies" or other sources; receiving products by mail or consignment carrier; or by personally bringing drugs into the U.S. As the FDA has stated on multiple occasions, all of these routes pose serious risks to patients. The risks are magnified when biological products are involved.
H.R. 1, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), would allow pharmacists and wholesalers to import certain drugs (not including controlled substances or biological products) from Canada to the United States only if and when the Secretary of Health and Human Services certifies to Congress that such importation will pose no additional risk to public health and safety and will result in significant cost-savings to American consumers.
Throughout the debate on drug importation, BIO's first priority has been to maintain the protection of the U.S. drug supply. No one will be helped if existing consumer protection standards are undermined by lax border controls.
Importation provisions passed by Congress in 2000 required a safety and cost-saving certification by the HHS Secretary, like that required in the 2003 Medicare bill. Neither current HHS Secretary Thompson nor the Clinton Administration HHS Secretary Shalala was able to make the required certification. Both Administrations stated they could not assure the safety of imported products, even with "safeguards" built into the legislation. The requirement for such a certification is essential to ensure that public health and safety are not jeopardized by prescription drug importation. As regulatory requirements and technology evolve, each future HHS Secretary must have the ability and obligation to assess the extent to which the safety of U.S. consumers can continue to be protected.
It is critically important, as well, to continue specifically to exclude controlled substances, biological products, and other product classes exempted in Section 1121 of the MMA, from importation. Biological products, many of which are injected or infused, are especially susceptible to contamination and have particular and highly sensitive requirements for production, storage, and shipment that, if not observed, can render the product ineffective and unsafe. Patient safety would be compromised by any relaxation of the current ban on importation of these products by anyone other than the original manufacturer or as otherwise currently permitted by FDA.
A number of bills have been introduced /will be introduced in Congress to legalize the importation of drugs into the United States from foreign countries. BIO will analyze and provide feedback on each individual proposal; however, we believe importation, a back-door to price controls, will have a chilling impact on innovation and the development of breakthrough treatments and therapies for American patients. Moreover, any bill that loosens import controls will result in a reduction of safety, a negative effect on a company's intellectual property rights, and may not result in cost-savings for consumers.
The Biotechnology Industry Organization (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 Jennifer Berzok, Director of Federal Government Relations at (202) 962-9200 or email@example.com.