API and drugmakers around the world who had eluded FDA oversight were expected to feel the heat after generic drugmakers kicked in new user fees that would help extend agency inspections around world. But a big piece of that money is being held hostage by the sequestration law.
Now members of Congress are feeling the heat as the industry's top lobby dog in Washington pushes them to amend the law so the FDA can tap the millions of dollars drugmakers are kicking in. According to The New York Times, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently made its position clear.
"By law, prescription drug user fees cannot be used for any purpose other than to support the FDA's human drug review program," Josephine C. Martin of PhRMA said. "The sequestration of user fees exacerbates the already severe budgetary constraints on the agency."
Congress is being pressed by lots of business interests upset that their industries are being hurt by cuts in federal spending stemming from the sequestration law. The law was negotiated two years ago to extricate Congress from a budget fight. But drug and device companies have an especially strong position because the cuts affect money they pay through fees, $1.7 billion a year. The law has kept the agency from spending $83 million, the Times says.
While some of the money is slated to help the agency approve drugs faster, some of it also was going to be used so the FDA could expand its inspections worldwide, particularly in developing countries like China, which has been the source of both adulterated APIs and counterfeit drugs. The agency has been fighting a burgeoning problem with fake drugs and just last month alerted healthcare providers that more shipments of counterfeit cancer drugs had made their way into the U.S. The agency has not said how the budget cuts will affect those plans, but FDA officials have pointed out that they now have more foreign than domestic plants to inspect.
- read the New York Times story