THE FDA’S RULING IS A POISON PILL TO THE RULE OF LAW AND TO PATIENTS

 

Some of the FDA’s own scientists have charged that politics, not science, is behind the FDA’s actions.

Rep. Joseph Crowley (D-NY)

It is no secret that the Obama administration has used the power of bureaucracies to create or change laws that run counter to their agenda. The DOJ, the IRS and the EPA have all been accused of using their bureaucratic power through regulation and political force, to punish, shake down, or cause harm to various individuals or industries. Not surprisingly, the FDA is not exempt from this practice.

In 2011, the Supreme Court ruled that generic companies did not control what their labels said and therefore could not be sued for failing to alert patients to the risks of taking the drugs. Under current rules, generic drug makers are not allowed to update such health warnings unless the FDA orders them to do so.  The pharmaceutical company or brand-name manufacturer that launched the drug will make changes as they discover risks, and the FDA approves them later, prompting changes in generic labels.

In 2013, the FDA proposed a rule (gave themselves the authority) to circumvent or rewrite the law. According to the FDA:

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.

The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.

This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use.  More than 80 percent of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date,” according to Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research.

The response to this ruling by the FDA has been met with much justifiable resistance, and the influence behind this ruling points directly at the cozy relationship among left wing advocacy organizations, trial lawyers and the FDA.

Citizens Against Government Waste reports:

The proposed rule represents a 180-degree change from what the FDA has espoused for more than 30 years.  Adoption of the rule would also mean that generic companies could be held legally responsible for any “failure to warn” tort cases. 

The rule would have two significant adverse results.  First, it would create is a huge opportunity for trolling trial lawyers.  Second, according to a 2014 study by Matrix Global Advisors, adoption of the proposed rule would increase the cost of generics by $4 billion per year:  $1.5 billion in government health programs and $2.5 billion in private plans.

In response to to this letter from three committeemen, Walter Harris, Deputy Commissioner of Operations and Chief Operating Officer of the FDA,  replied 4 months later.   He could not point to any specific statutory authority allowing his agency to make a change.  He admitted the the agency was responding to a petition submitted by Public Citizen– a left-leaning public advocacy group founded by Ralph Nader, and Mr. Harris also admitted that the FDA’s chief counsel and other FDA officials met with a representative from the American Association for Justice, the trial lawyers’ lobbying and advocacy organization– an organization that has lined the pocketbooks of Democratic organizations and lawmakers with millions of dollars:

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Generic drug companies argue that the rule exposes them to expensive lawsuits; would increase costs for an industry that has helped American consumers save billions of dollars: and create confusion because generic companies making the same drug might have different warning labels. This proposal has also been opposed by the manufacurers of these drugs for fear of the confusion this new labelling regime would impose on doctors, nurses and other health care professionals.  It also would be a boon to trial lawyers looking for more opportunities to sue the deep pockets of the manufacturers of these drugs by taking advantage of this new opportunity for expensive lawsuits.

Furthermore, the generic drug industry contends that generic companies do not have years of clinical data obtained through drug development and patent ownership, and that new warnings by any single generic producer would be based on sparse patient information. Only the FDA has access to the full range of data — from the brand-name producer, generic producers and other sources.

Ralph G. Neas, former president of the Generic Pharmaceutical Association said the industry’s proposal to make the FDA responsible would significantly speed up labeling changes but went further to say:

To delegate decision-making to a manufacturer who does not have all the relevant scientific information would not be responsible and could have harmful consequences…If you do something inconsistent with Hatch-Waxman, we will go to court because you will be exceeding your legal authority.

Although the FDA has not been granted the power from Congress to propose a new law in this manner, the FDA’s believes they have the unilateral authority to make laws. The executive branch does not have the power to pass a new law, or promulgate a regulation, without the consent of Congress.  But rule of law, as multiple state lawsuits have shown, will not stop the administration in creating new laws. In addition to this being a potential violation of the Separation of Powers between the executive and the legislative branch of the federal government, legislative actions by unelected bureaucrats is a dangerous practice.

The bottom line shouldn’t be measured in dollars, yet it seems that even when it comes to patient safety, which has  been protected by existing laws and subsequent Supreme Court rulings over many decades, the FDA is not immune to political influence.  Yet, in the words of the FDA and congressional oversight committee, the true bottom line is found in the answer to this question: where does the FDA have the authority to usurp the law of the United States? That answer is the antidote to the disease of big government.

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