It is refreshing to see this new willingness to fund the FDA; many of us have been calling for this for some time (see my March editorial). One of the issues that prompted Congress to act is the increasing awareness that the FDA does not have enough inspectors to keep up with the growth of drugs and APIs made at foreign facilities, a fact highlighted by the recent heparin crisis. In fiscal year 2007, the FDA conducted more foreign inspections than ever before, but the total, 322, still is not large. According to the commissioner's estimates, the additional funding should allow the FDA to conduct 120 more foreign inspections in 2009. These increases are good, but still insufficient to vet the more than 3,200 foreign facilities in the agency's database.
Because of this, another proposed new bill, the "FDA Globalization Act," would create user fees for inspections. User fees are not a perfect solution for regulatory funding, of course. One drawback is that they seem to discourage Congress from continuing to support needed budgetary increases later. That concern is not trivial. But these fees would provide important resources, and the industry is not objecting; PhRMA, BIO, and the Generic Pharmaceutical Association all have said they will support them.User fees also have an important benefit in this case, because they would help the agency keep a more accurate list of sites to be inspected. Currently, there is no cost for registering to import drugs to the US. As a result, many companies register, and then never actually sell products here, or they stop doing so without notifying the regulators.
Interestingly, the biggest concern about these proposed user fees has been raised by the FDA. The legislation, as proposed, would require that the agency inspect all foreign firms every two years, just as it does domestic firms. Janet Woodcock, back at the helm of CDER, says the FDA should be able to set its own inspection priorities based on risk assessments.
In principle, it makes sense to give the regulators flexibility to focus their resources where they are needed. But regular US inspections might create a healthy sense of respect for regulatory authorities at facilities around the world. The fear of a bad inspection also will have much more weight if the agency is given the authority to refuse to allow imports from firms that do not grant the FDA access to their facilities. The bill includes such provisions.
Of course, increased agency funding, whether through budget allocations or user fees, will not prevent another heparin crisis, because no amount of regulatory oversight will be sufficient to ward off counterfeiting. And no one has suggested that the agency's inspections reach all the way back in the supply chain to the ultimate sources of raw materials, where the heparin problem arose. That, as Woodcock pointed out, can only realistically be the responsibility of manufacturers, and it is not an easy challenge for them to meet either.
Nonetheless, a stronger FDA will benefit both the industry and the public. And it now looks like we are starting down a path to build up that strength. Finally.
Laura Bush is the editor in chief of BioPharm International, [email protected]