Search the internet for the keywords “FDA” and “gold standard,” and you’ll find plenty of articles and commentaries that laud the meticulous process used by U.S. Food and Drug Administration for developing drugs and medical procedures that are safe and effective for patients as the best in the world. The long, laborious, and expensive process for obtaining the FDA’s approval may be just that, yet supporters say the benefits far outweigh the costs. Do they always, though? And if not, how can the process be fixed?
Those are two questions that have been asked for many years, but lately, critics of the FDA’s god-like control over what medicine you can take and how you can become aware of their availability have begun to see victories in Congress and in the courts. That’s a good thing.
Last week, the U.S. House of Representatives finally passed a “right to try” bill that would give terminally ill patients quicker access to experimental drugs that might help them even though the drugs haven’t received final approval from the FDA. It’s been a long road filled with many defeats on Capitol Hill, but granting the desperately ill this lifeline has become an increasingly popular idea in recent years with Americans, and it saw early success at the state level. Vice President Mike Pence signed a “right to try” law while governor of Indiana, and 37 other states have taken similar action.
Federal action is needed, however, because the actual effectiveness of any state law aimed at giving terminally ill patients new hope for access to cures still in the development stage has been severely limited by the fact that the FDA is still responsible for federal oversight of treatments. Any drug maker willing to provide experimental drugs to a patient by citing a state law over federal policy does so at their own legal peril.
In modern America, the threat of being sued is often enough to dictate what course of action will be taken by anyone, especially a company that is accountable to a wide variety of shareholders and other investors.
The bill approved by the House addresses those legal concerns. As reported earlier here in Newsmax, the legislation shields drug makers from most lawsuits that might emerge from an injury or side effect of an experimental drug. It also states that the FDA cannot use such reports to delay or reject a drug up for approval — except under extraordinary circumstances.
The bill now goes to the Senate, and it faces an uphill battle there, too. Opponents argue
that the FDA already has a policy that gives terminally ill patients access to investigational medical products outside of clinical trials. According to the FDA, 99 percent of submitted applications for expanded access to almost 9,000 investigational drugs were allowed to proceed over a recent 10-year period.
So, why is “right to try” needed? Because it provides hope to families who, for whatever reason, don’t benefit from the FDA’s expanded access policy. President Trump and a majority of the members in the House are pushing for this change because they understand that giving hope to Americans facing their darkest hour is simply the right thing to do. Sometimes, that miracle drug really works, and who is the government to say you shouldn’t have access to it when all else has failed?
This challenge to the FDA’s authority is long overdue, and so is the challenge many have been waging over the agency’s refusal to allow pharmaceutical companies to promote medicines that have been approved for one purpose as options for other purposes, too.
Currently, drug makers are banned from promoting their prescription drugs to physicians for uses other than those specifically approved by the FDA. “Off-label” use of drugs, as it is known, is perfectly legal, though.
For example, the drug Corgard was approved by the FDA for angina and high blood pressure only, but it is also regularly prescribed by physicians for treating migraine headaches. Corgard is very effective in treating migraines for many people, but as effective as it is, the manufacturer can’t promote that use to physicians under the FDA’s rules.
That may be changing, though. Federal courts have ruled that the First Amendment guarantees a drug maker’s right to promote their products for off-label uses as long as the promotions are truthful.
As Henry I. Miller and Gregory Conko recently pointed out, the Second Circuit Court of Appeals in 2012 overturned the conviction of a pharmaceutical sales representative who told a doctor about off-label uses of Xyrem, a prescription drug manufactured by Orphan Medical, Inc. The court held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug."
Miller, a physician and molecular biologist, is the Robert Wesson fellow in scientific philosophy and public policy at Stanford University's Hoover Institution. Conko is deputy director of the George Mason University Law & Economics Center. They cite other decisions in which federal courts have ruled that truthful speech used in pharmaceutical marketing is entitled to the same level of First Amendment protection as other forms of commercial speech.
They go on to say that the current problem, though, is that “even if the courts do eventually establish a clear and unambiguous precedent holding off-label promotion to be constitutionally protected, that need not keep the FDA and federal prosecutors from hounding drug makers. The feds know that under federal anti-fraud laws, even charging a drug firm with mislabeling is enough to disqualify the company from selling any products at all to federal health programs, such as Medicare and the Veterans Health Administration. Even if the charge is later dismissed due to its unconstitutionality, an indictment alone could cost the firms billions of dollars in lost sales while the case is being litigated.”
Certainly, the FDA should be able to regulate commercial speech to make sure it’s not misleading or fraudulent. However, people suffering from migraines and other ailments shouldn’t be kept in the dark about potential treatments, either. Similarly, patients and their families who have asked for the “right to try” legislation shouldn’t be denied the hope that legislation provides them, either.
The FDA may be the gold standard, but it still isn’t god.
Bob Dorigo Jones is senior fellow at the Center for America, creator of the annual Wacky Warning Labels™ Contest, and the bestselling author of "Remove Child Before Folding: The 101 Stupidest, Silliest and Wackiest Warning Labels Ever." His weekly radio commentary, "Let’s Be Fair!" airs on radio stations across the U.S. To read more of his reports, Click Here Now.
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