The prospect of FDA corruption is one that's haunted the agency since its functions were established in the 19th century, as the Department of Chemistry in the US Department of Agriculture. Corruption in the FDA has grown in its subtlety, and whether or not something constitutes corruption can be open to debate on a lot of levels. Thankfully nothing has ever happened of sufficient significance to undermine FDA authority for any length of time.

Most claims of FDA corruption constitute instances of 'regulatory capture', the case where through lobbying pressure in Congress & through 'other considerations', such as hiring former FDA managers to consulting gigs after they're retired, the very companies that the FDA is supposed to be regulating have undue input into the running of the agency. Other areas that may or may not constitute FDA corruption stem from concerns about the agency not filling open positions after retirements, thus increasing the work load of all staffers in it. FDA history has seen many of these allegations.

These types of corruption charges boil down to the following complaints

• Product approval slowdowns
• Rushed product approvals without proper review
• Persistent understaffing and 'golden parachute' complaints

Product Approval Slowdowns

The FDA approval process takes time, and money, to navigate. Getting new products approved through the FDA is a significant barrier to entry for a new company or an entrepreneur, particularly if the product is of a medical nature or a food additive.

Clinical trials and human trials take years to set up and complete and cost anywhere from tens of thousands to tens of millions of dollars to complete depending on their scope and the number of variables being checked. There are several allegations made that the FDA can be induced to drag out the approvals process on certain drugs and food additives, to demand more rounds of testing, and to require a deeper standard of evidence when a new product is being tested into the market that competes with a popular existing product. There is currently an investigation going on about regulatory foot dragging on alternatives to the statins class of anti-cholesterol drugs.

This type of claim of corruption is difficult to corroborate, because the proper approval process should take substantial amounts of time. And the FDA is doing its job if it asks for further testing to clarify ambiguous results. However, because the FDA acts as a barrier to market, some approvals get abandoned not because the product doesn't have merit, but because the prospective manufacturer can't afford another round of testing.


Rushed Approvals

This type of FDA corruption is more spectacular when it happens, and sadly, it's been known to happen (with corroboration and documentation) since the 1930s. The mechanism is that a company will apply pressure to Congress through lobbyists, and Congress will apply pressure to managers within the FDA, to approve certain products. The most spectacular case in recent memory was the eventual reversal of the anti-inflammatory drug Vioxx, which had significant side effects when run through subsequent testing, and whose side effects were known during the initial round of testing, but were suppressed. A more recent case involves claims that during the last two years of the Bush Administration, managers at the FDA applied pressure on scientists to suppress data on breast imaging equipment to get it through the regulatory process more rapidly, because the manufacturer could bring it to market and make a profit – or go under because of another round of testing being required. Historical examples of this type of corruption (including lawsuits to throw out scientific data) date back to the 1910s.

There is evidence that this type of corruption and influence peddling happens regardless of which political party holds power in Congress or the White House; what keeps it in check is fairly regular changes in staffing at the FDA.


Staffing Level Concerns

Both political parties play this game, though it's more prevalent in Republican Congresses. The stunt is this: When people leave the Agency, due to retirement or taking jobs elsewhere, have the positions they'd fill become de-listed. This is primarily aimed at understaffing the enforcement side of the agency, not the product approvals process, though it happens there as well. This is often touted as "fiscal prudence", but is usually anything but. Government Accounting Office audits show that reducing staffing below a particular level actually costs the agency more due to overtime pay, with less enforcement happening per taxpayer dollar.

Corruption in the FDA is, sadly, a fact of life. We do not live in an ideal world where enforcement agencies are manned by incorruptible paragons of the human soul. We live in a world where people work for the agency as their job, and they worry about losing that job when the political winds that shape the agency blow against them.