Resident Fellow Scott Gottlieb

On Capitol Hill, debate about creating a legal pathway for approving copies of biologic drugs after their patents are up has focused on how much clinical testing should be required for the so-called "generic" proteins, whether the copies can be safely used interchangeably with their branded counterparts, and how much savings is really offered by follow on biologics or FOBs as they are being called.

Nobody has asked what financial and scientific burdens new legislation will place on the Food and Drug Administration. It's time people start.
 
To be sure, the story of FDA's financial woes isn't just a matter of flat funding, but also vast new mandates and authorities that never came with appropriate resources to fund the mission. In recent years, FDA's responsibilities for regulation of tissue products, for bioterrorism defense, and for food allergens are just a few areas where Congress foisted significant new roles on the agency but didn't adequately fund them. Unless the agency makes a case for the resource intensity that will be required to administer a pathway for FOBs, the new legislation being cooked up on Capitol Hill promises to be another big unfunded responsibility. FDA will have to somehow absorb the new requirements. Like other unfunded mandates, it will come at the expense of FDA's core programs.
 
FDA should not accept FOBs legislation that doesn't come with adequate money. While some of the legislative proposals include limited user fees on applications, the money contemplated will cover only a fraction of the real costs. The agency should stand firm and demand appropriate funding for the scientific reviews.
 
One can hold out only a little hope. While the FOBs are not true "generic" drugs since they are not interchangeable, lessons can be learned from the experience with small molecule, generic medicines. Like FOBs, the generic pills are viewed on Capitol Hill as money-savers--yet the resource needs for their timely review and approval gets short shrift, especially from the generic drug industry itself.
 
What is the hope that the generic firms, which have lobbied hard for legislation to create a short pathway for the quick approval of follow on proteins, will also make sure that the legislation comes with appropriate resources?
 
For insight into that question, follow the modest, $16 million proposal FDA put forward for generic drug user fees. FDA is hoping the new money will speed the review of traditional generic drugs but also enable it to develop more scientific experience in new areas of generic drug development such as liposomal drugs, certain dermatological creams, and inhaled drugs such as metered dose inhalers. For all of these drug categories, underdeveloped scientific standards for demonstrating bioequivalence are preventing the easier development of lower-cost safe and effective follow on products.
 
Issues of demonstrating similarity and equivalency are even more profound for FOBs. For these reasons and others, as the agency already knows, the review of applications for follow on protein products will be far more resource intensive for FDA than traditional generic drug applications.

Moreover, they will involve a lot of work from the new drug divisions. Right now, the generic drug group inside FDA doesn't have enough resources and personnel to keep up with its existing workload on small molecules, nor does it have scientific staff with expertise in biologics. It is unlikely that FDA's Office of Generic Drugs (OGD) will play more than an administrative role, at best, in the review of FOBs applications. It is equally unlikely that the new drug divisions will be able to easily accommodate the increased burden that the FOB applications will impose on their already busy workload.

Significant scientific hurdles could also slow development of FOBs and create persistent doubts about safety of certain follow on products if the agency does not have adequate resources to better develop new scientific principles to guide the review of these novel applications.
 
Yet the generic drug industry continues to stall on the user free proposal for the traditional generics. The industry has turned into a roughly $60 billion enterprise and the companies that comprise it are hardly the mom and pop ventures that existed when the original Hatch-Waxman legislation was struck that opened the way to more robust generic competition. The FDA's $16 million user fee proposal would be a relative pittance for these firms, but would go a long way to improving the quality of the scientific tools FDA has access to, and the timeliness of its work. What hope can be held out that the generic industry will take a different approach when it comes to fully funding the science around FOBs.
 
Right now, the generic drug trade association has used shifting arguments to resist the user fee proposal, while falling short of actually rejecting it.

At first they wanted to link the user fees to changes in how FDA handles citizen's petitions, which include documents that the branded drug companies sometimes file with FDA raising scientific arguments why the agency should not approve generic versions of their drugs. Now the generic drug trade association is conditioning its acceptance of user fees to a ban on so-called "authorized generics."
 
In fact, all of these arguments are stalling tactics to avoid a fundamental debate: Should an industry that has grown increasingly profitable through the benefits of legislation that tilted rules in its favor have a hand in supporting the science and the regulatory pathway that has made those profits possible. Hard to believe just a year ago, generic firms were arguing the biggest obstacle to their continued success was FDA's inability to keep up with the pace of their new applications. Now they are resisting a very modest user fee program.
 
Many generic drug makers are multi-million dollar global enterprises and it's time they start behaving that way. Giving short shrift to the resource needs of FDA for scientific review of traditional generic medicines--and now for FOBs--does not serve well the interests of the generic drug industry (which is being closed out of profitable areas for lack of science to support abbreviated pathways to approval of follow on products). It does not serve the interests of the agency that regulates these companies. And more especially, it does not serve well the public health.

Scott Gottlieb, M.D., is a resident fellow at AEI.