The president's request for a 19% increase in the US Food and Drug Administration's 2010 budget continues the positive trend
begun last year of gradually expanding resources for this underfunded agency. The additional $166.4 million for drug regulation
will allow for 346 more full-time employees, an important improvement. In seeking sufficient resources for the FDA's ever-expanding
responsibilities, however, the request includes both good proposals and bad ones.
The positive side includes requests for several smart new user fees. Requiring user fees for generic drug filings, for example,
is an excellent idea. Generics account for 70% of all US prescriptions, up from 50% four years ago, and the number of generic
drug applications has tripled since 2001.
In addition, these products, or at least their ingredients, increasingly are made abroad; the number of Indian facilities
named in generic drug applications grew from eight in 1992 to 963 in 2008. Inspecting these foreign facilities is challenging
and costly. As the FDA develops its fledgling partnerships with foreign regulatory agencies and expands its new offices abroad,
ensuring quality at foreign plants should become more effective and cost-efficient in the long run. But in the meantime, the
FDA needs resources to handle the generics workload on its own. These fees, furthermore, should not be tied to review timelines
like those in PDUFA. The monies are needed to catch up, not speed up.
On the negative side is a request for funding to enable the FDA to "develop policies to allow Americans to buy drugs approved
in other countries." I believe this effort is misguided.
I don't blame the FDA for this idea; it is only trying to prepare itself for what Congress may send its way. But rather than
accepting drug importation as inevitable, the agency should continue to oppose it, as it has in the past. The importation
of foreign drugs simply offers too many opportunities for malfeasance in the supply chain.
As it is, the agency is only scratching the surface in terms of monitoring imports of drugs already approved for sale in the
US. To see this, one only need examine the rest of the budget proposal. With the funds requested, the agency plans to double
the number of drug import inspections from 2,870 to 6,197, and to increase the number of import samples analyzed from 346
to 586. Yet even with these increases, the agency would still inspect only 2% of all import lines. These numbers make it clear
how few incoming shipments of foreign drugs the agency would effectively be able to monitor.
In the budget, the agency acknowledges that a big part of its effort to improve supply chain safety will be to hold the industry
accountable, recognizing that even a well funded agency could not police every move in the global pharmaceutical supply chain.
(Fortunately, many industry members also recognize this, and a few have formed a new coalition, "Rx-360," to harness industry
resources to tackle the challenge.)
Access to medicine needs to be improved, but drug importation is not the way to do it. The risks are too high, and it burdens
the over-stretched FDA unfairly. Properly funding the FDA to handle the ever-increasing load of generic drug reviews is a
better way to ensure affordable medicine with better guarantees of quality.
The FDA should continue to ask for the budget increases it needs. It should not, however, volunteer for new burdens that only
stretch valuable resources even further for tasks that are next to impossible.