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.