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FDA Is Pharma's Lapdog, Not a Watchdog

FDA Approved

Story at-a-glance -

  • The House Energy and Commerce Committee launched an investigation into the FDA’s Office of Criminal Investigations (OCI), particularly their handling of food, drug and medical device cases
  • A Reuters investigation previously found that more than half of all OCI cases are closed with no action taken
  • Agents at OCI have said they were told to avoid opening cases relating to other federal agencies
  • OCI agents have also questioned the need to pursue mislabeled injectable drugs, like Botox, from other countries, seemingly protecting high drug prices in the U.S. even though such drugs pose little public health risk

By Dr. Mercola

Many Americans have heard of the U.S. Food and Drug Administration (FDA), but few know the details of what they actually do. According to their own website:1

"FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation."

Unfortunately, this agency has a history of close ties to industry, including regulatory decisions that favor said industry instead of looking out for the public.

In September 2016, meanwhile, the House Energy and Commerce Committee launched an investigation into the FDA's Office of Criminal Investigations (OCI), particularly their handling of food, drug and medical device cases.

FDA Criminal Office Is Being Investigated

The committee is seeking answers to a number of questions, which they expect back by mid-October 2016.

Among them is why does the director of the FDA's criminal office, which is based in Maryland, work out of a South Florida office near his home? (This director, by the way, was paid more than $25,000 to move to Maryland less than two years ago, according to Reuters.)2

The House committee is also seeking statistics on OCI's arrests, convictions, case initiations and money recovered. A Reuters investigation previously found that more than half of all OCI cases are closed with no action taken.3

The review is also seeking clarification on how the FDA handled two critical reports that came from the Government Accountability Office (GAO) and the Health and Human Services Office of the Inspector General (HHS OIG).

The latter found the OCI lacked independence because it was housed within the Office of Regulatory Affairs, which conducts compliance inspections and is involved in determining OCI's budget.

Agents at OCI have also voiced concerns, including saying they were told to avoid opening cases relating to other federal agencies.

Reuters also reported on agents questioning the need to open cases to pursue mislabeled injectable drugs, like Botox, from other countries, even though they pose little public health risk. Reuters explained:4

"Current and former agents complain they have turned into the 'Botox Police,' spending thousands of hours chasing doctors who purchased authentic versions of Allergan's anti-wrinkle drug that were labeled for use in other countries.

Some agents say their efforts have done little more than protect the pharmaceutical industry's high drug prices in the United States."

How the FDA Controls the Media

Embargoes have been used in journalism since the 1920s. It's a deal between journalists and their sources, which gives the journalist access to a story on the condition that it's not published before a certain date and time.

Some institutions, including the FDA, further control media coverage by offering briefings to only a small selection of reporters. In January 2011, however, the FDA took this control to a whole new level with the use of a close-hold embargo.

The FDA allowed reporters early access to information about new medical device rules but, in addition to the regular embargo requirements, told reporters they could not seek comments from outside sources before the embargo expired.

Vincent Kiernan, Ph.D., a science journalist and dean at George Mason University, told Scientific American:5

"[When] you can't verify the information, you can't get comment on the information. You have to just keep it among this group of people that I told you about, and you can't use it elsewhere.

In that situation, the journalist is allowing his or her reporting hands to be tied in a way that they're not going to be anything, ultimately, other than a stenographer."

In other words, through the use of the close-hold embargo, the FDA gets journalists to report only what they tell them, without outside commentary or analysis.

News of the close-hold embargo triggered backlash, including from the Association of Health Care Journalists (AHCJ), which prompted the FDA to backtrack and change its tune, according to a media policy they released in June 2011 — at least on paper.

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FDA Breaks Its Own Rules and Continues to Stifle Journalistic Freedom

In reality, the use of close-hold embargoes has continued among the FDA and other institutions. According to Scientific American:6

"The FDA, too, quietly held close-hold embargoed briefings, even though its official media policy forbids it. Without a source willing to talk, it is impossible to tell for sure when or why FDA started violating its own rules."

In January 2014, however, it's known that the FDA used a "strict, close-hold embargo" prior to their launch of a new public health ad campaign. Again in April 2014, the FDA forbid journalists to contact third parties regarding new e-cigarette rules set to be released until after the embargo expired.

The resulting stories stayed on task in delivering the FDA's message with little analysis or critical coverage, but one piece, published in The New York Times, gave the close-hold embargo away by stating:7

"FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document."

The FDA was not happy that their secret had been shared, nor were the news outlets that had been excluded from the early briefing.

News Outlets Continue to Kowtow to FDA's Demands

To date, few news outlets have pushed back against the FDA's favoritism to certain media outlets or their restrictive rules regarding reporting. Scientific American continued:8

"No matter how rare it might be, there is documentary evidence of its happening multiple times, and each instance since 2011 is a violation of the FDA's official media policy, which explicitly bans close-hold embargoes.

This policy still stands, just as it did before the last close-hold embargo. The smart money says that the agency's unofficial policy still stands, too — and the favoritism and close-hold embargoes continue. It is apparently too sweet an arrangement for the FDA simply to walk away."

Other Federal Agencies' Close Ties to Industry

Another leader in public health, the U.S. Centers for Disease Control and Prevention (CDC), should be cracking down on corporations promoting products linked to poor health and disease. Instead, they appear to have taken at least one company under their protective wing.

Earlier this year, for instance, Barbara Bowman, Ph.D., former director of the CDC's Division for Heart Disease and Stroke Prevention (DHDSP), left the agency unexpectedly, two days after her close ties with Coca-Cola were revealed.

Bowman reportedly aided a Coca-Cola representative in efforts to influence World Health Organization (WHO) officials to relax recommendations on sugar limits.9 Bowman, however, was not the only CDC official looking out for Coca-Cola.

Uncovered emails now suggest that Dr. Michael Pratt, senior adviser for Global Health in the National Center for Chronic Disease Prevention and Health Promotion at the CDC, has also promoted and led research for the soda giant.10

Federal Regulations Often Favor Large Corporations While Bankrupting Small Business Owners

In related news, the majority of Americans believe government regulation is needed to protect the public interest, but many overlook the fact that such regulations often boost businesses' bottom lines.11

Take, for instance, U.S. automotive safety regulations, which boost sales for a manufacturer of seat belts and air bags. Industry lobbying also sways regulations to meet their needs. As Bloomberg reported:12

"'There are two principal ways to make a better mousetrap: Make a better product or get the government to pass a regulation that hurts your competitor more than it hurts you,' says Richard Williams, who spent 27 years writing regulations for the FDA."

Such regulations often harm small businesses, which lack the resources to keep up with regulatory changes. While large corporations may be able to absorb such costs, small companies may go bankrupt. Meanwhile, such regulations limit smaller entities' ability to enter the marketplace. Unfortunately, in the U.S., federal agencies are often nothing more than pawns for corrupt business.

When the agencies pretend to be guarding consumers but end up shielding industries from liabilities, carefully controlling media messages and creating barriers for entry to eliminate competition, they need to be eliminated, as they are doing far more harm than good.