A new drug safety bill that is aimed at giving the Food and Drug Administration the ability to better police the global prescription medication market was unveiled by House Democrats yesterday. Should the bill be successful it could have an enormous impact on increasing the safety of prescription drugs that are imported into the U.S.
Over the past several years the prescription drug market has become increasingly global in its scope with more and more manufacturers seeking cheaper production costs by manufacturing drugs overseas.
In 2008 tainted batches of the anticoagulant drug Heparin that were manufactured in China lead to dozens of American deaths.
The FDA received much publicized for ridicule for its failure to catch the tainted product before it was introduced into the American market; however, in the following months it became clear that the FDA did not have the funding or the man power to ensure drug safety in this ever expanding global economy.
Currently international manufacturing facilities are inspected with far less frequency than domestic facilities and if we truly want to ensure the safety of the drugs we are taking and prescribing it is imperative that this issue is addresses soon.
The new bill calls for “parity” between foreign and domestic inspections, meaning that no matter where a facility is located it would be inspected with same frequency as domestic manufacturing facilities.
The new bill would require manufacturers to ensure the “safety of their supply line” and would even give the FDA the much needed power to mandate recalls of drugs it determined to be unsafe.
While this bill might seem like a no brainer to many, the bills future is certainly in danger. With no initial Republican supporters the bill could be left for dead should a republican controlled Congress take office at the November elections.
Representative Henry Waxman of California said that he would work with the FDA and “all stake holders to move the legislation forward” as quickly as possible.