The FDA: Ensuring the Next U.S. Disaster

Similar to other regulatory bodies, a properly functioning FDA is critical for ensuring the nation’s health and safety. However, the fact is that the FDA is inadequately prepared to carry out its stated role.  This assessment is not my own. It comes from the FDA itself. As a result, the U.S. faces the risk of one or more catastrophes.

by Mike Stathis

The Food and Drug Administration (FDA) is like many federal regulatory bodies that were established for the sole purpose of protecting U.S. consumers. One could reasonably argue that the importance of the FDA is much greater than the Securities and Exchange Commission (SEC), and even the Federal Trade Commission (FTC).

The critical responsibilities of the FDA require additional levels of accountability and oversight. However, unlike the case seen in the SEC and FTC, there are no partnering agencies or outside bodies to oversee the actions of the FDA.

While the SEC and FTC are held accountable to the (largely useless and criminal) U.S. Congress, there are other regulatory and enforcement bodies that help serve as checks and balances. For instance, the FTC works with a host of state and federal agencies, including the FBI. Certainly, the FBI has become incompetent and largely unreliable, but let’s be honest; the agency is not entirely useless (although some could make a good case for the contrary).

The FTC is very responsive to consumer complaints regarding fraud and other illegal activities. The FTC also works closely with the Attorneys General of each state.

While the SEC claims to be responsive to complaints of fraud, this is really not true. The fact is that the SEC protects the largest criminals, while policing the small guys in order to give the impression that it is doing its job.  In reality, the SEC has become a complete joke and an accomplice in fraud committed by Wall Street.

Let’s have a look at the agencies the SEC works with. First, there is FINRA, (Financial Industry Regulation Authority) which claims to be the largest independent regulator of securities.  Next, we have the CFTC (Commodity Futures Trading Commission).  The secret here is that the SEC really runs FINRA and the CFTC.  The SEC also works with state securities regulators which have more independence and can pursue securities violations without going through the SEC. Although the SEC is only able to file civil charges in cases of securities fraud or other violations of securities laws, the agency works with the Department of Justice when it wants to pursue criminal charges.

In reality, the SEC also relies on investment professionals and experts in academia who most often uncover widespread fraud. However, even when fraud has been exposed and reported to the SEC, the largest criminals always seem to escape punishment. Instead, the SEC targets small players and holds press conferences so as to create the perception that it remains effective in policing the securities market.

[Not one single executive from Wall Street has faced civil suit by the SEC.  Civil charges are almost always the first stage of what later turns into criminal charges by the Department of Justice. The SEC works very closely with DOJ prosecutors to prove their case. So if you are waiting for the criminals who destroyed your retirement savings, caused you to lose your job and maybe your home, all while destroying the global economy, do not hold your breath. The criminal syndicate in complete control of the U.S. would never permit real justice because it would mean they would be in prison.]

Unlike the SEC and FTC, who work with numerous agencies and departments, helping to provide a bit of accountability and oversight, there is no real body that really works with the FDA.

Even with the assistance of numerous agencies, the SEC and FTC have been ineffective in achieving their stated mission. As you might imagine, with no external accountability, the FDA is positioned to do much more harm.

While the FDA claims to work closely with the Drug Enforcement Administration, the Consumer Product Safety Commission, the Department of Agriculture and many other agencies, both state and federal, this is simply not true for practical purposes.

The lack or real oversight and accountability seen in the FDA has become a huge problem that could lead to one or more episodes of widespread disaster as you shall see.

So let’s have a brief look at the responsibilities of the FDA.

The FDA was established in 1906 as a branch of the Health and Human Services Department (HHSD). Although most of its legal authority was established by the Food, Drug and Cosmetic Act of 1938, it has been granted additional legal authority by Public Health Service Act, portions of the Controlled Substances Act, the Federal Anti-Tampering Act, and many other pieces of legislation.

Prior to 1970, the FDA was primarily a law enforcement Agency and relied far less on science: the issues of adulteration and misbranding could be handled by well-trained inspectors. The need for PhDs and MDs was modest, and very few were employed by the Agency.

Beginning in the 1970s however, FDA became a modern science-based regulatory agency. The bulk of its work shifted from the courts to regulatory decisions made within the Agency with the advent of pre-market review and approval requirements for FDA-regulated products.

Science forms the basis of all regulatory decisions. FDA employees lacking adequate scientific support subject the approval process to delays, or worse, poor decisions. Therefore, effective regulation requires that the scientific competency within FDA matches or exceeds an applicant’s knowledge.

Today, the FDA is entrusted with the critical responsibility of regulating and supervising the safety of drugs, foods, vaccines, medical devices, blood products, dietary supplements and cosmetics. Thus, this agency serves a very important role in the U.S. economy by ensuring the safety of approximately $1 trillion in consumer products, or 25 cents of every consumer dollar spent annually.

The importance of the FDA in the nation’s security is similarly profound. The FDA plays a central role in protecting the nation from the potential effects of terrorist attacks, such as anthrax, smallpox, attacks on the food supply, nerve agent attacks and radioactive contamination, as well as from naturally occurring threats, such as SARS, West Nile virus and avian influenza.

Despite the awesome responsibility entrusted to the FDA, there is compelling evidence of dangerous inadequacies within its many divisions.

I have previously discussed how the prescription drug industry continues to engage in fraud. So where is the FDA amidst all of this?

Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science.

But the drug industry does its part to assist with the FDA’s lack of consumer protection by shuttling over $500 million each year in drug user fees. This serves as bribe money to keep the FDA aligned with the incentives of drug makers.

In addition to the cosy relationship the FDA has formed with drug makers, we see many more problems with this agency.  An internal review of the FDA concluded that the agency is “structurally broken,” and as a result, has placed the health and safety of the entire U.S. population at risk. An internal investigation of the FDA identified numerous areas of concern addressing the weaknesses and critical need for a radical restructuring of the agency.

Below are just a few of the findings from the report:

Finding: The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

Finding: The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.

Finding: FDA does not have the capacity to ensure the safety of food for the nation. During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years, and cosmetic manufacturers even less frequently. The Agency conducts no inspections of retail food establishments or of food-producing farms.

Finding: The development of medical products based on “new science” cannot be adequately regulated by the FDA.

Finding: There is insufficient capacity in modeling, risk assessment and analysis.

Finding: The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.

Finding: The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.

Finding: The IT workforce is insufficient and suboptimally organized.

Finding: The FDA has experienced decreasing resources in the face of increasing responsibilities.

Finding: Recommendations of excellent FDA reviews are seldom followed.

These findings illustrate just a few of the many problems found within America’s healthcare system.

I want you to think carefully about the vital responsibility of the FDA, combined with the agency’s own analysis of its capabilities.

Next, imagine the possibilities of a national disaster just waiting to happen.

Perhaps the FDA really stands for the Federal Disaster Administration.

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