FDA reform effort suddenly looks very real

Drug Store News, Oct 20, 1997 by James Frederick

Since they returned from their August recess, the nation's lawmakers have been busy. Besides work on a slew of budgetary issues, both the U.S. House and Senate have grappled with landmark issues affecting the health of millions of Americans and the future profitability of the branded and generic pharmaceutical industry, the medical device business, the cosmetics and food industries -- not to mention retail pharmacy.

I'm talking about the bid to overhaul and modernize the U.S. Food and Drug Administration. The movement gathered steam last month as I attended the Generic Pharmaceutical Industry Association's legislative conference on Capitol Hill.

It was a ripe time to be inside the Beltway. Senators and Congressmen were literally dashing back and forth between the Capitol and the conference site between votes, and almost every speech they gave to GPIA members was interrupted by the sound of beepers calling the legislators back for a crucial vote or debate.

Shadowing the generic group get-together with lawmakers were the FDA reform proposals making their way through both halls of Congress a few blocks away. Given the fact that the FDA regulates the sale of about $1 trillion in U.S. goods, it's no wonder FDA reform got a lot of attention from lawmakers and generic industry people at the event.

GPIA has lent strong support to the FDA overhaul, whose major aims are to speed new drug and medical device applications, better allocate resources, improve accountability and modernize outdated review and tracking practices within the vast agency. Those effort were fueled this year as the Oct. 1 deadline for reauthorization of the Prescription Drug User Fee Act loomed.

Concerns about reform

Despite its support, the GPIA has voiced several concerns over FDA reform. One big one centers on the issue of uniform standards for bioequivalence, so that states don't have the power to pre-empt federal generic policy. The generic industry is also concerned over the dwindling resources afforded the FDA's generic drug division, and was buoyed by a recent proposal to add an extra $1 million in funding to that division to speed the approval process, which still takes far longer on average than the 180 days mandated by Congress.

In a speech to GPIA members, Pennsylvania Senator Arlen Specter voiced support for the added funding and predicted it would remain in the final FDA reform bill. "I believe that the funding for testing is really indispensible...the delays in the FDA on all sides are really unconscionable," Specter said. "We really ought to be providing the resources. I note the Office of Generic Drugs has suffered a decrease of 40 full-time positions since 1994, and at the same time the generic drug applications increased very substantially, like 40 percent."

In my mind, $1 million more for the Office of Generic Drugs isn't enough. Since 1994, the OGD has lost 40 full-time employees to budget cuts, while the generic drug application backlog has risen steadily, to more than 150 pending applications that are over the six-month review deadline, according to GPIA. The FDA also remains mired in outdated procedures and outmoded technology.

Branded drug makers should be concerned, as well. For one thing, they're paying $88 million a year in user fees to fund the FDA review process, according to Sen. Orrin Hatch [R-Utah].

"I am not a fan of user fees. You and I both know they are really a tax," Hatch said frankly. "But the reality is that fees for new drug reviews are not going away. They are an $88 million line item in the budget, and the fact is the appropriators will not find another source for those dollars."

What's more, the agency's top-heavy structure and skewed allocation of resources for administrators at the expense of clinical testing and drug application reviews hurts both branded and generic manufacturers.

Hatch acknowledged as much, and also expressed strong support for additional money for generic oversight. "FDA's record is, to put it simply, abysmal," he told attendees. "The agency simply doesn't have the resources it needs to do the job with generic reviews."

Confidence in reform package

Rep. Richard Burr [R-N.C.], who authored the FDA reform proposal in the House, voiced confidence that an overhaul would pass the full House and Senate. "My belief is that modernizing FDA is the single greatest contribution I could make to the health care of the American people. If it helps your industry along the way, it helps patients across this country," Burr said. "I am confident that in the end, responsible heads within the House...will see that we can ... modernize the FDA, streamline the process, form a partnership between industry and the agency and, in the end, bring drugs faster and cheaper to the marketplace."

Burr noted that Congress was "very aware of the problems with the allocation of personnel," adding, "Most members would agree with you that we have too many [FDA] people in things like public relations and ... Other areas that don't facilitate the approval process of applications."