BIO Testifies on Drug Safety Provisions of Draft FDA Globalization Act
“BIO and our members will continue to work closely with the Food and Drug Administration (FDA) to ensure that our nation’s drug supply is safe, secure and reliable, and that the American public can be confident that when they use an FDA-approved drug, the medicine will be safe and effective and work as intended. The ‘closed’ imported drug regulatory system has been successful because our industry has implemented rigorous manufacturing and quality control practices. Although the overall quality of drug products in the U.S. is still very high, the recent FDA announcement regarding the contamination of heparin is a reminder that we need to continue to be vigilant in our efforts to ensure the safety, efficacy, purity and potency of prescription drugs and biologics.
“We appreciate the opportunity to provide feedback to the Subcommittee as it considers legislative options for strengthening the ‘closed’ imported drug regulatory system.
“The FDA is woefully underfunded given the enormous responsibility entrusted to it by Congress and the public. Additional appropriations are necessary to adequately fund the FDA and specifically the foreign inspection and import program. If new user fees are created by the legislation, the amount and use of any new user fees should be clear to ensure transparency and accountability. Any new inspection user fees paid by BIO members should not duplicate existing registration and establishment fees, and should be specifically allocated to supporting FDA’s drug and biologic inspection programs and not used to subsidize the inspections of other regulated parties’ establishments.
“If Congress enacts new requirements, it is critical that they build upon and strengthen the existing regulatory framework for the approval and manufacture of drugs and biologics and avoid imposing confusing, duplicative, or vague new mandates.
“It is also important for new legislation to recognize the significant differences between biologics and small molecule drugs, as well as between and among different types of biologics. The FDA must have the responsibility and discretion to ensure appropriate testing of safety, purity and potency based on each particular product.
“Finally, this ‘closed’ system for imported drugs and drug products is an essential element in ensuring drug safety in the U.S. Efforts to broaden importation of drugs will undermine efforts to strengthen the system and add to the FDA’s already heavy burden.”
The full text of Greenwood’s written testimony is available at http://bio.org/letters/Greenwood_Testimony_Import_Safety_050108.pdf.
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About BIO
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.
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