GAO to Cite FDA Faults At Congressional Hearing - The Real FDA Scandal

Wall Street Journal – January 2008

GAO to Cite FDA Faults At Congressional Hearing

The Real FDA Scandal

We at Infinite Health Resources have long been critical of the FDA. On the other hand we also share FDA alerts and safety concerns on our website as this info becomes available from the FDA, which is weekly.
However, until the funding of the FDA is altered in some way to get Big Pharmaceuticals out of the nearly $500,000,000 it annually hands the FDA, we will continue to suffer adversely from much of their drug approval decision making.
In this global economy with imports from the world over. Much needed improvement in oversight is needed. This in our view is as threatening as securing our border from illegal immigration and possible terrorist infiltration.
Tainted food, toys and pet products have already been imported. These are just a few that were found. Surely there are more. More funding from the government to make sure a government agency, like the DFA, is operating sufficiently is long overdue.
This issue has not come to bare in our presidential campaign. Could those campaign dollars have anything to do with that? We wouldn’t bet the farm on it.

Read on:

GAO to Cite FDA Faults At Congressional Hearing
The Food and Drug Administration can’t keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign companies, according to congressional investigators.

In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found “weaknesses” in the agency’s over-sight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials’ own estimates, overseas makers of the riskiest products such as peacemakers, were examined only every 6 years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.

The GAO testimony on medical devices will be part of the hearing’s broader effort to high-light an issue that has turned up in reports and critiques over the past few years: concerns the FDA’s resources and technology aren’t enough to meet its regulatory responsibilities to oversee drugs, food and other products.

The subcommittee also is expected to discuss a separate, harshly worded report released in November by a group of the FDA’s own advisers that warned the agency needs substantial resources to deal with emerging scientific developments.

The report, from a subcommittee of the FDA’s outside Science Board that included members and advisers from industry as well as academia, said the agency “cannot even keep up with advances in science.” An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities – including food, drugs and medical devices – in 2006

The hearing also is expected to focus on the FDA’s oversight of food, an issue that has sparked concerns in the wake of recalls. The GAO will testify that the FDA’s plan to step up food regulation, unveiled last year, could help but the agency needs to issue more specifics. The FDA’s staff and resources haven’t kept up with the food-safety work load, the congressional investigators will say.

As the Bush administration comes close to releasing its proposed budget, the testimony will add weight to calls by some groups for a budget boost for the FDA.

An FDA spokeswoman said the agency will comment on the GAO testimony at the House hearing. She said the agency “appreciates the Science Board subcommittee’s efforts to draft a report” and will work with the full board on the issue.

Worries about the FDA’s fundings have been strong enough to spark a lobbying effort, first launched in 2006, that brought together industry and patient groups, as well as former agency officials. The money appreciated for the FDA by Congress for fiscal 2008, which ends October 1 was a bit more than 9% compared with the year before, according to Steven Grossman, deputy executive director of the Alliance for a stronger FDA.

The hearing also will highlight safety concerns that have been raised in several hearings by Michigan Democratic Representatives John Dingell and Bart Stupak, who are chairmen of the full Energy and Commerce panel and the Oversight and Investigations Subcommittee, respectively. Mr. Dingell has introduced a bill seeking to bolster inspections of imported food and drugs through new industry fees.

The medical-device testimony will say that FDA officials estimated U.S. markers of the highest risk products are examined, on average, every three years. Domestic manufacturers of moderate risk devices get inspected every five years. Overall, the GAO estimated, the FDA inspected about 27% of the registered U.S. manufacturers each year and about 5% of the foreign facilities.

In a statement, AdvaMed, a trade group that represents medical-device makers, said the industry “has an excellent safety record” and it supports “additional appropriations for FDA.”

The Real FDA Scandal
So Members of Congress and the press are working up another panic about the state of the Food and Drug Administration. The place is a mess all right, but as usual the most alarming news is receiving almost no attention.

Washington is responding to a series of investigations concluding that the FDA cannot "adequately" monitor America's food supply and medical products. One of the FDA's outside advisory panels, the Science Board, reports that the agency is in "a precarious position," in part because it is chronically underfunded. The Government Accountability Office chimes in that, at the FDA's current pace, it would take 13 years to inspect every foreign drug plant exporting to the U.S. and 1,900 years to inspect every overseas food factory.

That last factoid may be true, or not, but it does raise the question of whether such a crackdown is possible, never mind desirable. Monitoring 100% of foreign imports -- or 10%, or whatever -- would be so onerous that it might as well be a ban. Yet lapses like adulterated Chinese toothpaste are exceedingly rare, mainly because companies have every incentive to police themselves. (Ask Mattel about its toy import nightmare.)

Still, it's generally agreed that the FDA could use more cash, and the White House's 2009 budget requests a 5.7% increase. But what no one reports is that the Science Board says these shortfalls crop up because Congress hasn't increased FDA funding in proportion to its burgeoning regulatory demands. Over the last two decades, Congress has expanded the FDA's reach more than 127 times; it now oversees about 25 cents of every dollar spent in the U.S.

The Science Board's most important, and distressing, finding is that the FDA bureaucracy "cannot even keep up with the advances in science" -- and not solely due to a lack of funding. While "the world of drug discovery and development has undergone revolutionary change," the authors write, the FDA's "evaluation methods have remained largely unchanged over the last half-century." (Our emphasis.)

Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.

The observation comes on page three, which leads us to suspect that Congress's hand-wringers haven't even read the study. Here's a refresher: "The mission of getting safe and effective drugs to patients in a timely manner is currently threatened by inadequate expertise and capabilities," the Science Board notes.

Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence "to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced" and "to support innovation in the industries and markets that it regulates."

The Science Board authors propose that the FDA "modernize current regulatory pathways," especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.

The FDA uses rigid statistical techniques to evaluate developmental drugs, even when the lives of terminally ill patients are at stake. Many advanced immunotherapies for cancer, for instance, are held hostage to the FDA's old models, which still insist on crude mortality rates and the large average effects detected in clinical trials. Better metrics would include improving the quality of life or slowing the progression of tumors, or focusing on targeted populations. The Science Board says that "there is an urgent need for developing . . . new statistical methods that are most appropriate for the data generated by new areas of science."

Take Junovan, a medicine for a rare pediatric bone cancer. Junovan's successes in a clinical trial were "only" demonstrated with a 94% level of statistical certainty, instead of the FDA-mandated 95%. Avastin, a revolutionary biologic currently used against lung and colorectal cancers, also looks like it will get a thumbs-down as a treatment for metastatic breast cancer. While the evidence shows that patients lived longer before their symptoms got worse, they didn't live longer on average. Refusing to consider "progression-free survival" as a drug benefit is not only unscientific, but morally hideous.

The real scandal is that these policies are the product of the FDA's institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it's so much easier to say, "spend more money."


Perhaps that's why the Science Board ends on a mordant, but all too accurate, note: "Finding: Recommendations of excellent FDA reviews are seldom followed."Read more at www.infinitehealthresources.com, click the Resource Center.