The FDA Approval Process

Anyone paying attention to the growth of the natural products industry over the last 50 years is aware of the cloud that hangs over them in the form of "the threat" that could be issued at any time by the FDA, to force one or all of their natural products to be labeled as "a drug" and forced off the market unless they put it through the FDA $3+ million dollar approval process.

The threat of such a declaration by this tyrannical government agency that is known to be in bed with the multi-million dollar pharmaceutical industry could be tantamount to a death-knell for a small vitamin or herb company trying to stay in business. And while no one wants any company, large or small, to be producing and selling dangerous products, there is a world of difference between a product that is actually dangerous to consume, and something the FDA calls dangerous because it interferes with pharmaceutical company profits.

While the FDA approval process is slightly different for various classes and categories of applications, the one thing they all have in common is the tremendous expense required by the company owners and sponsors of the various substances submitted for approval. It has often been pointed out that the need for companies to pay huge sums (in excess of $3 million per drug) to the FDA to cover the costs of their testing and approval, is a clear scenario of the fox guarding the hen house.

The FDA proudly boasts on its web site that "American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world." If you removed the word safest, the statement might be close to the truth. Consumer groups like Public Citizen, a watchdog over the FDA, routinely find it necessary to battle this agency's findings in order to remove from or keep dangerous pharmaceuticals off the market, often publicizing the need and calling for the removal of lethal drugs months or years before the FDA acquiesces to step up to the plate.

Drug companies chummy with FDA officials make it known what their expenses were in getting a drug approved and the FDA coincidentally may forestall action to recall the drug until the company has recouped its expenses and made a tidy profit to boot, notwithstanding consumer injuries and deaths in the interim.

What's Necessary to Get the Job Done

In document HRG Comments on Section 406(B) of the FDA Modernization Act OF 1997 (HRG Publication #1457), Public Citizen stated that this act "requires the FDA to consult with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups and the regulated industry to discuss how the Agency can best meet its statutory obligations under the Federal Food, Drug, and Cosmetics Act (FFDCA), while meeting the mandates of FDAMA '97.

"The irony... lies in the fact that the purpose of the FFDCA was consumer protection, while the clear intent of FDAMA '97 is to further the economic well-being of multinational pharmaceutical and medical device companies at the expense of the public's safety. The FDA has been compelled by Congress to accept the drug industry as a "stakeholder" and has recast the [FDA] from the role of regulator and public protector to that of industry's "partner" in the marketing of record numbers of new drugs, a role that has already, and will continue to have, serious consequences for the safety of the American public."

Add to this the unconscionable ruling during the 1990's to allow drug manufacturers to advertise their wares directly to the public, some even before FDA approval. These companies are now legally allowed to advertise directly to the sickly, elders, and desperate citizens. One example is Aricept, a so-called drug for Alzheimer's disease found to be partially effective on less than 30% of its users. Prescriptions were being written for it before it was FDA approved so that insurance didn't cover it, and many elders found themselves facing out-of-pocket monthly expenses of $140 or more for just one drug they thought they desperately needed.

In the testimony of Sidney Wolfe, MD, Director of Public Citizen's Health Research Group (HRG) before the Senate Commerce Committee on Consumer Affairs on DTC (Direct to Consumers) Advertising in July 2001, Dr. Wolfe stated "There is little doubt that false and misleading advertising to patients and physicians can result in prescriptions being written for drugs that are more dangerous and/or less effective than perceived by either the doctor or the patient. This can then lead to a subsequent toll of deaths and injuries that would not have occurred had safer, more effective drugs been prescribed... both physicians and patients-will be harmed by prescribing
decisions about which drugs to use based on all-too-frequently false and misleading information from advertisements which are much less likely to be stopped because of [the current] poor enforcement by the FDA."

It's clear that consumers have few reasons to trust the regulatory agencies in the government to watch their backs. Yet prescription drugs that are not well-tested or whose contraindications and side effects are known to be as serious as the symptoms they are intended to cure and could be fatal, are routinely approved and permitted on the market by Food and Drug Administration. Now, this same agency that has no time or funding to throw at doing their regulatory job right concerning strong pharmaceuticals, can at any time, and frequently has, turned their hand to oppressing and prosecuting businesses that sell natural products that have a logarithmically smaller chance of harming users. One has to ask, what's wrong with this picture?

The FDA Is Broken

In an article entitled Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice published in The Journal of the American Board of Family Practice [17:142-149 (2004)] on Health Care Policy by Richard A. Deyo MD, MPH, Depts of Medicine and Health Services and the Center for Cost and Outcomes Research, University of Washington, Seattle, Dr. Deyo's abstract states "Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs, devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations.

• The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices.

• It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices).

• Many believe post-marketing surveillance of drugs and devices is inadequate.

• A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic.

• Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees.

• FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.

• Because controversies relating to internal conflicts or political issues are infrequently reported in scientific journals, this discussion draws not only on scientific articles, but also internet resources, news accounts, and interviews. The goal was not to be exhaustive, but to provide examples of tensions, conflicts,and gaps in the FDA process.

Dr. Deyo goes on to address a common misconception of consumers toward FDA approval of drugs, explaining that "for a new drug to win approval, the FDA does not require it to be better than products already available-only that it be effective (better than nothing) and fairly safe... In some cases, the definition of "effective" is narrow and may not address the end results of therapy. A drug that achieves a "surrogate outcome" may be approved if it lowers cholesterol, lowers high blood pressure, or improves heart rhythm-without knowing if it improves life expectancy."

Obstacles Are Nearly Insurmountable

Apart from those in this country suffering from obvious starvation and malnutrition, our general population is one of the sickest in the world due to the travesty of the consumption of improperly cared for and killed animals in slaughter houses, business decisions prevailing over humane and sanitation issues affecting government meat packing inspections, and the large agribusinesses oppressing small family farms, organic growers, and raw milk dairies because they compete with the industrial farming complexes only in it for the money.

Add to that the imported products intended to increase trade with other countries, and government regulations imposed on them to heavily spray flowers, vegetables, and other produce with insecticides, pesticides, and herbicides. Within the country, consumers must buy GMO grains because they include nearly the entire corn and soy crops of the U.S. and that of much of Mexico and other South American countries (although banned in the European Union since 2006), and the gene giant Monsanto is working on extending their monopoly to GMO wheat as well.

City dwellers have little access to family gardens anymore and the economy being what it is, just about everyone is leaning toward city living just to locate a job, or a second job, to make ends meet. So if you were an herbalist or an individual whose health had been restored by the use of some natural substance, you would immediately think that you weren't the only person who might benefit from it. And many others thinking like that might want to started companies, to both help people and make enough money from it to live and continue helping people.

Traditionally trained doctors may see little miracles from the use of natural substances and sometimes recommend them quietly, more interested in helping their patients than the drug companies. The word spread and we found out that Aspirin® is a drug company name for White Willow bark, a natural substance used as a common pain killer and analgesic in generations past. Who knew?

And the patenting of new cholesterol lowering drugs resulted in the FDA declaring the identical natural substance to a currently patented drug, Red Rice Yeast, "a drug" so it was only obtainable by prescription. Would it ever occur to them to make the drug itself non-prescription? Of course not. Again the question comes up, what's wrong with this picture?

Forgetting the Past May Mean Missing Its Successes

So much has been forgotten in the race to build big business. But somehow we can't be doing everything right, just look at the economy. Yet in past generations when people cared about each other and built businesses from quality products with moral intentions, the economy was doing well. What happened to "life, liberty, and the pursuit of happiness"? We have certainly lost our perspective if you scrutinize the changes that have taken place that elevated our government to chief cook and bottle washer over every available area of life from food production to banks and insurance.

So now this country's government agencies are persecuting small businesses that promote 'natural medicine' here, because they do not have the financial clout of the big drug companies to defend themselves. Yet the finances of those same drug companies pays for the raping of the Amazon rain forests and destruction of its plants and herbs that are imported here and distilled to make the very "prescription drugs" that are worth billions. Skilled scientists and herbalists that would be favored and supported in many other countries, live in fear that they will be arrested, when their sphere of influence is so minute they couldn't possibly kill the number of people that legal drugs kill annually.

Russia, Ecuador and Panama are known for their herbalists. Throughout Europe, Asia, Australia, and even South America, 'natural medicine' and natural practitioners are favored and patronized. Once revered in the U.S. along with its teachers and adherents, such practitioners and teachers are now persecuted and derided as ignorant fanatics.
How did this come about?

Things changed dramatically in 1980 with the Bayh-Dole Act, which gave universities, small businesses, and non-profit organizations the right to patents developed using federal research funds. Then in 1987, an Executive Order extended this right to all industry. Also in 1980, a Supreme Court decision (Diamond v. Chakrabarty) permitted the patenting of genetically modified organisms and allowed various tax credits for them. A new trend was emerging.

A review by Peter Lurie, MD, MPH, of Sheldon Krimsky's book Science in the Public Interest: Has the Lure of Profits Corrupted Biomedical Research? (HRG Publication #1722) was published in The Journal of Public Health Policy in late 2004. In the review, he said "But are these developments ultimately in the public interest? Krimsky thinks not. These arrangements have contributed to a series of what he terms "Tales of the Unholy Alliance" that collectively are an embarrassing scar on the research enterprise. Among the tales, all compellingly told, is the drug company Knoll's suppression of a manuscript already in galleys at the Journal of the American Medical Association demonstrating that Knoll's Synthroid held no advantage over several generic thyroid hormone competitors. In another, an NIH scientist, already compensated at $144,000 a year, received almost $80,000 from Warner-Lambert, but nonetheless participated in the decision to include Warner-Lambert's now-banned diabetes drug Rezulin in an NIH-sponsored clinical trial. The Rezulin arm of the study had to be stopped when a patient died of liver failure; the scientist participated in that decision too."

Since this time, un-patented natural substances could never have the financial potential that prescription pharmaceuticals had because they had been discredited by immoral men with financial interests. And today these laws are still used to discredit and demean even the very same herbs that are used to create many of the drugs used today. If you pay attention in a hospital or a doctor's office when someone asks an innocent question of their doctor or nurse "Well, can't I use something natural instead of this prescription drug?", the medical party line they were taught in medical school is, "No my dear, I know you're in pain, but they aren't patented and only patented substances are FDA approved." And that is said as if either being patented or having FDA approval guaranteed the consumer's safety, but neither is true. Sometimes, it is patently false.

But there is no money in un-patented natural products and thus they are said to be worthless; worthless, that is, except to those who have used them and been restored from lethargy, poisoned systems, and all forms of malnutrition and pain. Instead of using these substances as an arsenal against maladies that there are as yet no effective drug therapies for, medical professionals look down their noses at natural products, lowly herbalists, and natural practitioners as if they were deceived or deceivers, and with knowing looks and winks behind their backs, tell them they need to wait for research to provide that wonder drug that will cure all ills.

How Long Does It Take?

If that wonder drug were discovered this very moment, you still couldn't have it. Because it takes about 12 years and US$350 million to get a new drug from the laboratory to a pharmacy shelf. It must undergo around three and a half years of lab testing even before an FDA application can be made to start human trials, and it would be delayed by being one of the 1000 substances in the pipeline at the same time that ever get that far.

If it does, the official guidelines demand that it enter three phases of clinical trials:

Phase One requires about a year for it to be tested on 20-80 healthy volunteers to establish its safety and profile.

Phase Two requires about two years and 100-300 patient volunteers to assess its effectiveness.

Phase Three involves about three years and its use on 1000-3000 patients in clinics and hospitals where it is monitored for effectiveness and adverse reactions.

After that, it takes another two and a half years to submit an application of about 100,000 pages to the FDA for final approval. Only then does it become available to doctors.

If the official guidelines are overridden, as happens more and more these days as financially viable drugs are fast-tracked "for the public good", the initial trials might be far fewer and of much shorter duration, but then the safety and effectiveness outcomes are also far less certain. Ordinarily after Phase Three, drug companies continue to report cases of adverse reactions and other clinical data to the FDA. In the case of fast-tracking, they simply do it after the drug is on the market. As they say, "You pays yo money and you takes yo chances."

The pharmaceutical industry invests close to US$13 billion a year in new drug development, and historically, that figure doubles every five years.

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