SOCMA Comments on FDA Drug Safety Announcement
FOR IMMEDIATE RELEASE
July 9, 2008
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Manager, Public Relations & Communications
Washington, DC – The Synthetic Organic Chemical Manufacturers Association's Bulk Pharmaceutical Task Force releases the following statement responding to Health and Human Services Secretary Leavitt's announcement of new FDA enforcement efforts:
'The FDA's partnering with foreign regulatory bodies to coordinate inspections of foreign manufacturing facilities and the concentration of resources on highest risk facilities, is much needed and should alleviate some of the backlog of inspections. Inspections are a vital component of any well meaning and well working regulatory regime.
If this initiative is to work, then inspections cannot be watered down for the sake of collaboration. The lowest common denominator cannot be the basis for any inspection process going forward.
Secretary Leavitt also stressed the FDA's desire for information sharing between multiple government bodies and industry, as well as for the FDA to become a verifier for drug safety standards. These are appropriate roles that should assist industry in ensuring the safety of our nation's drug supply.
We have long said that industry has a role to play. It manufactures, ships, distributes and imports materials. During this process, industry has a responsibility to ensure the quality of its products. An appropriately structured certification can be one tool to accomplish this goal.
While we applaud the FDA's efforts, we are not sure it goes far enough. The Agency must be given enough resources to repair the technical problems, as well as train and retain staff as laid out in the FDA's own Science Board Report.
To this end, we believe Secretary Leavitt's FDA announcement today is a good start, but must be put into action quickly. Delay only allow more time for another unfortunate event to occur. Additionally, this effort would work in conjunction with the legislation currently under consideration in Congress. We would like to see both the legislation and the newly announced initiatives go forward this year.'
SOCMA is the leading trade association, serving the specialty-batch and custom chemical industry since 1921. SOCMA’s nearly 300 members employ more than 100,000 workers across the country and produce 50,000 products valued at $60 billion annually. For more information please visit www.socma.org.
ChemStewards® is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement program. ChemStewards was created from industry’s commitment to reducing the environmental footprint left by member’s facilities. Industry created ChemStewards to meet the unique needs of the batch, custom, and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of synthetic and organic chemicals, ChemStewards is helping participants reach for superior EHS&S performance. To learn more visit www.chemstewards.com.