Nickel and Diming FDA

Everyone agrees FDA needs more money to do its job. Its not getting it. Does that mean the drug safety law will just end up making a bad situation worse?

Everyone agrees FDA needs more money to do its job right. Why isn’t it getting it?

Michael McCaughan

"I don’t think there is anyone in this city who can tell me what the Food & Drug Administration Amendments Act will cost to implement," former FDA Commissioner David Kessler said during an American University drug safety dialogue sponsored by Pfizer Inc. "We are only going to learn that over a period of time."

One thing is clear, though: whatever FDAAA does cost to implement, the law will not be accompanied by major new funding for the agency. Yes, FDA will be getting a big raise in the amount of user fees paid by regulated industry for product reviews. But all of its other activities rely on Congressional appropriations—and they have not been a priority for Congress for a long time. ( See "Missing the Opportunity to Fund FDA," The RPM Report, April 2007 (Also see "Missing the Opportunity to Fund FDA " - Pink Sheet, 1 Apr, 2007.).)

"FDA is just not doing well on the Hill when it comes to appropriations," Kessler said. "We are not giving the agency the resources they need."

Kessler went even further: "Let’s face it: FDA is dying on the vine."

For FDA and the members of the Institute of Medicine committee on drug safety, whose 2006 report helped shape the FDA Amendments Act (FDAAA), that sounds like the worst possible news. The legislation itself should be a much needed turning point for FDA and the pharmaceutical industry, a chance to move beyond the political and regulatory reactions to Vioxx.

But if it ends up taxing FDA’s strained resources to the breaking point, it could end up making a bad situation worse.

Broad Consensus in Favor of More for FDA

When the drug safety legislative debate began in earnest at the start of 2007, FDA’s position was unambiguous: more than it needed any new authority, it needed the resources to do the tasks it was already assigned. ( See "The Power of the Purse," The RPM Report, February 2007 (Also see "The Power of the Purse: FDA Seeks More Money, Not More Authority" - Pink Sheet, 1 Feb, 2007.).)

The Institute of Medicine firmly believed FDA needed better tools too, but the drug safety committee wholeheartedly agreed that without adequate funding, nothing it recommended would make much difference.

"An agency whose crucial mission is to protect and advance the public’s health should not have to go begging for resources to do its job." That is how the IoM put it in the summary of its recommendations on drug safety.

When the committee met to follow up on the report in March, the warnings about the importance of resources became even more dire. The committee’s summary of the March meeting, published August 31, starts with a chapter on the need to give FDA more resources.

And industry agrees. Big Pharma already pays plenty to support product reviewers through the user fee program, and the new legislation will mean even higher fees in the years ahead. But no one thinks that’s enough to ensure that FDA can attract and retain competent reviewers and stay on top of all of the other assignments it has to handle.

As WilmerHale attorney Scott Lassman puts it, "a fully staffed-up and fully resourced FDA is good for everyone." Lassman helped negotiate the $400 million user fee extension as senior assistant general counsel for the Pharmaceutical Research & Manufacturers of America before joining WilmerHale in September. He highlighted the importance of giving FDA the resources it needs during a discussion of the new user fee program for television ads during the Food & Drug Law Institute’s advertising & promotion conference September 17. ( See "The New Era in DTC: FDA Plans Fees, Schedules, and Creative Advice," in this issue. (Also see "California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits" - HBW Insight, 24 Apr, 2024.))

That’s why two different coalitions were organized to lobby for higher funding for FDA. Both have industry support as part of a broad base of consumer and other stakeholder interests.

Four-Fifths Funded

It hasn’t been enough.

Both the House and Senate Appropriations committees have provided for a modest raise for FDA—that’s big news in itself, after several years of flat-lining FDA’s budget so that it couldn’t even cover the cost-of-living increases for its employee base.

But it is far, far short of what the agency’s advocates on Capitol Hill say is needed. How short? About $300 million, according to an analysis by the FDA Alliance. ( See Exhibit 1.)

In the context of the federal budget, $300 million isn’t much. But it would take a 20% increase over the amount Congress is willing to give the agency to fill in that gap. And, as Kessler points out, that figure does not include the cost of implementing FDAAA.

Nor, for that matter, does it include the cost to FDA of enacting FDAAA. FDA regulatory policy director Jarilyn Dupont pointed out at the FDLI conference that the legislative process—and the interest in FDA it has stimulated—have carried a high cost of their own. She didn’t put a dollar amount on the total, but noted that FDA officials have testified more often in 2007 so far than they did in the entire two years of the 109th Congress. ( See Exhibit 2.)

Food for Thought

With everyone talking about FDA, why can’t the agency get the money that everyone thinks it needs?

"We are at a disconnect," Kessler says. It may be that the federal government is "just out of money with regard to discretionary funding and that is the issue."

Or is it something else? Kessler suggested that the concerns about food safety—which is much more directly relevant to most of the members of the Agriculture Appropriations Committee that oversees FDA—may be interfering with other priorities. "Maybe the biggest problem to drugs right now are foods," Kessler says. "Maybe…until we solve food we are not going to be able to get the attention back and the resources to really be able to take advantage of FDAAA."

Noting that the chair of the appropriations committee for FDA in the House, Rep. Rosa DeLauro (D-Conn.) is "a close, close friend" who believes in good government, Kessler nevertheless suggested that the problem may simply be "the Ag/FDA balance, which is always out of sync." At a similar conference earlier this year, Kessler joined several former commissioners in suggesting that FDA needs to have its appropriations taken out of the Agriculture committees. ( See "What’s Old is New," The RPM Report, April 2007 (Also see "What's Old Is New: Former Commissioners and the Future of FDA" - Pink Sheet, 1 Apr, 2007.)).

Even without considering the funding consequences, Kessler continued, the relentless focus on the agency’s ability to assure the safety of products under its purview is taking a toll on the agency. ( See "Dog Days at FDA," The RPM Report, May 2007 (Also see "Dog Days for FDA: Agency Weathers a Stressful Spring" - Pink Sheet, 1 May, 2007.).)

"This constant battering that we have seen of late is only going to get worse," Kessler predicted; there is a set of hearings on food safety coming up, he said. "You know those are going to be brutal for the agency. Now you want me to recruit a young person into that agency?"

Another former commissioner, Mark McClellan, agreed with Kessler about the funding challenges facing FDA. McClellan, though, was more optimistic—or at least more diplomatic—about the current appropriations cycle.

"The Senate Approps bill…put some of a bump up in the resources," McClellan said. "It is only a fraction of what is really needed, but there is starting to be an impact from these coalition efforts." McClellan is a member of the Coalition for a Stronger FDA, which, along with the FDA Alliance, is one of the coalitions pushing for enhanced FDA funding (See "Double Down: Two Coalitions Push for Enhanced Funding for FDA," The RPM Report, February 2007 (Also see "Double Down: Two Coalitions Push for Enhanced Funding for FDA" - Pink Sheet, 1 Feb, 2007.).).

McClellan, however, also agreed with Kessler about the impact of the recent austerity budgets for FDA. "You can’t carry out these kinds of complex critically important tasks on the resources the agency has, so you get in situations like you see now with the food imports."

"When I was at the agency in 2002 we were able to get a huge increase in resources related to food and import safety, able to hire 600 inspectors, but over the last four years because of failures of appropriations to keep pace with even the agency’s wage increases for its workers that additional staff has been completely attrited away."

"So here we are with five times as many food imports as we had a decade ago and much more complex imports coming in and fewer people able to review the imports." And food imports are just one portion of the flood of imports FDA is responsible for regulating.

"So, yes,its easy to hold the hearings to beat up on the agency for not doing enough, but what is really needed is to give the agency the resources it needs."

And both McClellan and Kessler agree, the stars should be aligned to make it happen. "It’s a unique time where everybody has come together and its not producing results. The question is why," Kessler said.

"There is not nearly enough of an impact," McClellan agreed. "Why aren’t we seeing more given how absolutely critical these issues are for the public health and how absolutely consistent the message is from all stakeholders and all experts who have looked at this?…We have more work to do."