AAHF

Summary of Senate Food and Drug Administration Revitalization Act
By William A. Duncan, Ph.D., Lobbyist for the American Association for Health Freedom

There has been a great deal of concern among members of the health freedom community about the FDA Revitalization Act that passed the U.S. Senate on May 9, 2007, 93 to 1 with six not voting.  While there may be other reasons to oppose the bill (FDA reform, institutional bias, etc.) the bill, in fact, does not affect the authority of the Dietary Supplement Health and Education Act (DSHEA) or diminish protection or increase FDA oversight over dietary supplements.  Click here to take action. 

S. 1082 - An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.  This bill has gone by the following names: Prescription Drug User Fee Act (PDUFA), FDA Revitalization Act, and Enhancing Drug Safety and Innovation Act of 2007.

Why It’s Must-Pass Legislation

Congress has a schedule for reauthorizing legislation that regulates federal agencies and programs.  This allows Congress to periodically reexamine past policies, and change the underlying law when necessary to deal with crises that have emerged or to improve management practices in an agency.  Thus, the FDA Revitalization Act is characterized as a “must pass” bill.  Failure to pass a “must pass” bill is considered irresponsible by members of the legislature.  Further, any efforts to block such passage will meet utter defeat.  There is a genuine effort by the vast majority of legislators to compromise for the public good that comes about as a result of the bill.

If the FDA reauthorization bill is not passed in time, all new drug and device development at the FDA ceases.  There would be no new antibiotics, no new development of artificial limbs for accident victims, no new treatments for chronic disease.  Everything would be frozen in place and FDA would just be left to enforce the current status quo. 

Drug Safety

In the Senate reauthorization there are two provisions which the drug companies have historically opposed.  There is now a post-approval surveillance system in place and when a drug warrants it, a risk evaluation and mitigation strategy.  This has come about directly because of the known drug safety problems our nation experienced surrounding Vioxx and the SSRI antidepressants.  These problems demanded that Congress take a serious look at the FDA and the approval process.  The results of those scandals were so profound that the drug companies agreed that the surveillance system and evaluation and mitigation strategies were necessary.  They have also agreed that all studies will be published including negative results.

This provision may eventually be an opportunity for dietary supplements.  If a drug is shown to use up certain nutrients, and taking supplements of those nutrients reduces risk, it could be listed on the label and recommended for those who choose to take it.

There were considerable modifications of the legislation from what was first introduced by Senator Kennedy, what came out of the HELP committee, and this final bill.  In giving new regulatory authority to the FDA, Congress wants to be extremely cautious that they do not hurt access to new and innovative prescription drugs or devices.   (Read our previous article on the Senate bill 1082.)

The Senate bill creates a surveillance system for adverse prescription drug events.  This will now allow cooperation with academic institutions that have the expertise to evaluate the signals from that surveillance system and ensure that both patients and doctors have the information they need to make decisions about the risks and benefits of medical drugs.  Senator Tom Coburn, M.D., the U.S. Senate’s only practicing physician, stated, “I know that it is impossible to ever completely eliminate drug risks. The right approach is to provide accurate risk information and preserve the doctor-patient relationship.  I appreciate the progress made in the bill towards this end.”

In addition, a dangerous provision that dictated what doctors could prescribe what drugs was removed from the bill.  The provision would have permitted the FDA to directly interfere in the State’s prerogative to regulate medicine.  The doctor-patient relationship has thus been preserved.  As Dr. Coburn stated, “Medicine is not just a science; it is also an art.”  The American Association of Health Freedom would have directly and vigorously opposed that provision as it would have greatly harmed the practice of medicine.

S. 1082 will ensure that patients have access to potentially life-saving drugs that might not otherwise be approved because of known adverse events caused by the drug.  This legislation establishes that the agency will not limit or restrict distribution or use unless a drug has been shown to actually cause an adverse event!  Now that this principle has been adopted for drugs, it could be used to reverse some of the abuses the community has seen in the recent effort to break DSHEA by destroying Ephedra.  (Note that with Ephedra, the only thing the FDA had as evidence was 150 deaths where the herb was present, like in the medicine cabinet.  There was not evidence of ingestion, and no causal effect was shown!)

The legislation also holds pharmaceutical companies accountable if their advertisements are false or misleading. 

There is a user fee agreement in the legislation that requires fees to be paid to increase funding for the FDA to handle the workload created by drug and device approvals.  The user fee agreements for prescription drugs (PDUFA) and medical devices (MDUFAMA) have been negotiated between industry representatives and the FDA.  The industry indicates what it will pay for faster drug approvals and the FDA commits to achievable performance goals.  If it were not done this way then the taxpayer would be footing the bill for drug and device development, without cost to the drug manufacturers, and without taking into account work load.  Maintaining timely and efficient patient access to lifesaving and life-enhancing medical drugs and devices is a win for the industry, doctors, and patients.  This bill will both help keep the pipeline of innovation moving forward and improve communication and understanding between agency staff and manufacturers.

Dietary Supplements and FDA Reauthorization

Dietary supplements are specifically excluded from the scope of this bill.  First, in SEC. 605. ADULTERATED FOOD REGISTRY, the adverse events bill for dietary supplements and prescription drugs is specifically mentioned.  Thus the industry, in writing their own bill, avoided having Mr. Durbin, an opponent of dietary supplements, write the provisions that would have applied to the dietary supplements industry.  In addition, I looked for traps I would have put into this legislation if I were trying to harm dietary supplements.  These traps are not there. 

The Reagan-Udall Foundation, a separate government sponsored research institution, only deals with dietary supplements as part of their overall mission regarding food safety.  There is no new regulatory authority, as a “colloquy” on the Senate Floor between Senators Kennedy, Harkin, Kennedy and Enzi demonstrated. 

Opportunity to Make a Fundamental Change to the FDA:  Removing the Institutional Conflict of Interest

The dietary supplements community has the power to affect change in the way business is done at the FDA.  The passage of DSHEA involved well over 1 million people, and still holds the record as having the most mail and phone calls than any other subject.  If that power was still channeled by the community, we could make a fundamental change to the way the FDA does business, and reduce the threat to our dietary supplements in the process.

One of the challenges faced by the industry is the repeated attempt by a few bureaucrats at the FDA to treat dietary supplements like drugs despite the law.  They insist on trying to apply double-blind, placebo trials to dietary supplements, which are food.  That model of research is fine for drugs, when there is huge research dollars available, and when the effect and safety of a molecule are unknown, but this method of doing research is certainly not feasible or necessary for dietary supplement research.  In fact there are other, far less expensive research methods that yield valid scientific data.

Unfortunately, if your only tool is a hammer, the whole world tends to look like the head of a nail that needs to be pounded.  So, one of the most important things the community could do is help the FDA by breaking up this one-size-fits-all department that oversees approval of new drugs, adverse events reporting, withdrawal of drugs from the market, approval of label claims for drugs/devices and dietary supplements, and enforcement of all of the previous items. 

There is an institutional conflict of interest that is the fundamental organization flaw at the FDA and causes the kinds of problems both with drug development and enforcement, and with their hubris and attempts to grab yet more power.  Our system of government is set up to divide power, because power corrupts and absolute power corrupts absolutely.   The solution is to split the FDA’s power into two separate agencies and move tracking of adverse events and enforcement out of the group that does the initial approval of drug and device applications.

This institutional conflict of interest is simply an internal bias not to embarrass “your agency,” or “your department” if a particular bureaucrat approved a drug or device that later turns out to have problems.  It is not about individual dishonesty.  Thus a bureaucrat or department with such a conflict might be slow to react to adverse events reports, or slow to make appropriate warnings to physicians and consumers about these unanticipated side effects.  Then, when action finally is taken, it may be even more draconian than if action had been taken when a problem first arose.

Congress has dealt with most institutional conflicts of interest in the government.  For example, the Department of Energy controls nuclear materials, not the Department of Defense.  The Office for Human Research Protections (OHRP) at HHS was created to oversee human subject research throughout the United States.  This was originally at the National Institutes of Health and it was found that having human subjects “protected” by the agency doing the “research” on those subjects did not afford the amount of protection needed. 

The two agencies where Congress has not dealt with this are at the FDA, as described above and the Centers for Disease Control in the vaccine program.  There the same people who approve vaccines also promote them and administer the adverse events reporting system.  This institutional conflict of interest has lead many to question the integrity of the CDC because of adverse events that are under reported or simply denied.  Dr. Dave Weldon, a member of Congress from Florida, has introduced HR 1973 Vaccine Safety and Public Confidence Assurance Act of 2007 to help solve this institutional conflict at the CDC.

When the American Association for Health Freedom’s leadership, Drs. Sherri Tenpenny and Robban Sica, visited the House and Senate members and staff during our recent visit to Capitol Hill, they received encouragement to pursue this effective strategy.  We spoke with Congresswoman DeLauro’s staff (who is the Chair of the subcommittee that oversees FDA’s budget.)  He well understood this particular conflict of interest and was very receptive to taking this idea to the Congresswoman in the upcoming House FDA reauthorization debate.

The community can have a major impact on FDA by asking their members of Congress, in both the House and the Senate, to address the Institutional Conflict of Interest at the FDA.  This single thing, while the FDA reauthorization bill is moving through the system on the fast track, could do more in the next five years to protect dietary supplements from FDA abuse than any other single thing the community could do.  No longer would a single department at the FDA approve, track adverse events, and enforce actions against drugs that do not measure up to their initial approval.  With this power divided, adverse events reporting for nutritional supplements and over the counter drugs will also be moved to where the information can be properly evaluated, and those who wish to treat dietary supplements like drugs would not have enforcement power to harass the community frivolously.

We encourage each of you to write your members of Congress and ask them to address the FDA’s institutional conflict of interest by dividing this power.  This could appropriately be sent to the Agency for Healthcare Research and Quality, an agency charged with following and improving the health care system in America, or even to a new independent agency.  Please visit our website at www.healthfreedom.net and send your elected officials that message today.  Click here to take action.