Within You, Without You: FDA's Problems Spell Trouble for Public Health

“We were talking--about the space between us all 
And the people--who hide themselves behind a wall of illusion 
Never glimpse the truth--then it's far too late--when they pass away.

We were talking about the people…who gain the world and lose their soul.” – George Harrison

The Food and Drug Administration is one of the most important federal agencies, with a mission to promote and protect the public health by helping safe and effective products reach the market in a timely way; monitor products for continued safety after they are in use; and help the public get accurate, science-based information needed to improve health. The FDA has a vast regulatory scope that includes safety and use of pharmaceuticals (including use for livestock), food safety, cosmetics, personal care products, medical devices, bottled water and much more.

Not surprisingly, the FDA’s mission to keep the public safe from a wide variety of products and devices has meant that, historically, it has been a target of tremendous political pressure from regulated industries -- including particularly the chemical industry in all its various guises (pharmaceutical, industrial and pesticides) -- as well as Congress and the White House.  The industry devotes enormous resources to influencing the decisions of the FDA, whether directly – via a vast army of paid scientists and top legal talent -- or indirectly -- through lobbying of members of Congress and the White House.

Consider, as a small illustration, the report in this week’s Washington Post on the pay for the CEOs of the major trade lobbying groups in Washington, DC.  Topping the list was former Congressman Billy Tauzin, who until recently led the Pharmaceutical Research and Manufacturers Association (PHRMA) – who earned a total compensation of $11.57 million dollars in 2010.  Pamela Bailey of the Grocery Manufacturers Association (whose members include both food conglomerates and chemical companies) was 7th with a total salary of $2.8 million, and former Congressman Cal Dooley of the American Chemistry Council (which represents the major chemical manufacturers) ranked 9th at $2.29 million dollars.  These CEO salaries are merely a small reflection of the vast sums devoted to their full lobbying and “regulatory advocacy” apparatus. According to the Post, the chart is comprised of those trade associations “that have spent more than  $17.5 million influencing policy in Washington since 2009.”

A lengthy article in the New York Times this week painted a sympathetic picture of the FDA as an agency unable to serve the public good because of political pressure from a skittish and sometimes hostile White House. The article touched only briefly on the influence of powerful corporate interests in FDA decision-making. In our experience, the FDA has consistently bowed to corporate pressure and failed to take action – even where legally required to do so -- to protect the public from harmful chemicals.

In addition to the array of external forces that continually threaten the FDA, the agency is troubled and hobbled from within where a culture has developed that shuns transparency, clings to outdated scientific and risk assessment methods, and will go to extreme lengths to avoid taking actions that will result in actual regulation or prohibition of the use of chemicals that pose a risk to public health and the environment.

Just last week, in a decision that scientists decried as "ludicrous" and "illogical," the FDA rejected our petition to remove the hormone-disrupting chemical BPA from food packaging. By law, the FDA is supposed to prohibit the use of a food additive if it cannot be proven to be safe. The agency's decision flew in the face of a large body of scientific evidence pointing to the harmful effects of BPA, linking early exposure to low levels of BPA to breast cancer, prostate cancer, cardiovascular disease, obesity, and reproductive harm.

The agency stopped short of stating that BPA is safe, instead arguing that they need to continue studying the chemical before making a final decision. But scientists remain concerned that the method FDA is using to study BPA and other endocrine-disrupting chemicals remains deeply flawed, despite criticism from its own science advisory board.  In a statement following the denial of NRDC’s petition, the Endocrine Society expressed concern that the FDA is “ignoring the entirety of available scientific data.” The statement further noted: “The FDA’s approach to discounting studies in the regulatory process does not allow for a thorough examination of the data and hinders the agency’s ability to ensure appropriate regulation of EDCs [endocrine disrupting chemicals].”

Pleading the need for further study as an excuse for failing to act decisively to protect the public is a tactic the FDA has used before, most egregiously in the case of antibiotic use in healthy livestock. This practice is so prevalent on factory farms that it accounts for nearly 70 percent of all the antibiotics sold in the United States. For 35 years, the FDA ignored its own science demonstrating that dosing healthy livestock with antibiotics leads to the spread of dangerous drug-resistant bacteria that can infect humans.  But last month, in response to a lawsuit filed by NRDC and other public interest groups, a court compelled the FDA to take a stand on the issue. It will have to revoke its approval for dosing healthy livestock with penicillin and tetracyclines, unless the pharmaceutical industry can prove that their use in animal feed is safe. Meanwhile, NRDC and our allies are still fighting the FDA in court over the agency's stance on a number of other medically important antibiotics that are being overused by the livestock industry.

Yet another decision that has been pending at the agency for decades – to prohibit the use of so-called “anti-microbial” chemicals that the agency has already determined are no more effective than washing one's hands with plain soap and water.  Evidence continues to grow that exposure to the chemicals triclosan and triclocarban are widespread, and that they pose threats to both public health and the environment.  As with the use of antibiotics in livestock, NRDC has sued FDA to compel the agency to finally take the steps necessary to complete an action it began in the mid 70sand never completed.

It took 35 years and a protracted court case to get the FDA to stand up to the pharmaceutical industry and help make sure that antibiotics are used for sick people, not healthy cows and pigs. Action on triclosan and triclocarban has also been pending for decades. Meanwhile the FDA could be reviewing the science on BPA for another 35 years. When it comes to protecting the public from harmful chemicals, the FDA's response has been woefully inadequate, and sadly predictable: they dodge and delay.

To a great extent, the American public relies upon powerful officials in Washington DC – some well-known, and others largely unknown -- to protect people from dangerous products and unsafe chemicals they use or are exposed to on a daily basis.  The President and officials in the White House, members of the House and Senate, leaders at FDA, are by definition successful and have “gained the world.” But if they fail to use their power to protect the public, what can they say they have really done in their time of “public service”?