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FDA’s War On Sudafed Shows Need For Reform

The Food and Drug Administration has declared war on … Sudafed. Agency bureaucrats are concerned that an ingredient called phenylephrine found in products such as Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion doesn’t actually relieve congestion despite the results of earlier studies. The FDA is launching a public comment period to address these concerns and may ultimately revoke these medications’ over-the-counter status based on the evidence and feedback it receives.

While reasonable people can disagree about the efficacy of drug ingredients such as phenylephrine, the agency has a disturbing track record of keeping safe, effective medications out of consumers’ hands. The FDA should relax regulations and allow for popular, effective medications to be available over the counter. Regulatory reform can empower patients and change millions of lives for the better.

The current controversy over phenylephrine was the predictable product of misguided federal regulations. Reason senior editor Jacob Sullum notes that a more effective decongestant called pseudoephedrine was the go-to in cold remedies such as Sudafed, but lawmakers whisked pseudoephedrine behind the counters because of drug war paranoia. The Combat Methamphetamine Epidemic Act of 2005 sought to prevent meth cooks from getting their hands on the ingredient, and now, federal purchase limits and record-keeping requirements have all but quashed pseudoephedrine. Drug manufacturers were forced to respond by subbing out pseudoephedrine for phenylephrine, and the FDA is only now raising a fuss.

Sniffly patients aren’t the only casualties in the war on OTC products. At every turn, regulators have insisted that consumers cannot be trusted to purchase products without doctors’ and pharmacists’ approval. Before a new medication is approved by the FDA, manufacturers and regulators must see eye-to-eye on whether the drug will require a prescription.

In theory, prescription status is warranted when medication risks are high and/or the treatment regimen is confusing. Plenty of lifesaving medications, though, currently require physician sign-off despite being low-risk and straightforward to use. And that’s a problem when Americans overwhelmingly use OTCs as their first line of defense and rarely see doctors. Doctor’s visits are expensive, embarrassing, and time-consuming, resulting in patients not seeking out the prescriptions they need.

Even switching a few medications from prescription to OTC could save thousands of lives. An increasing body of evidence shows that statin medications not only significantly reduce the risk of heart attacks, but also reduce “the risk of developing various cancers, and improve … the outcomes for cancer patients.” Meanwhile, side effects are minor and resolve once patients stop treatment. Additionally, selective estrogen receptor modulators such as raloxifene can reduce the risk of developing breast cancer by 40%. While blood clots are a very real side effect of these medications, risks are low especially if patients don’t have a history of blood clots. Surely, patients who have seen their family members struggle with breast cancer can weigh these risks against the significant benefits of these therapies.

Even if regulators are leery of making certain medications completely OTC, they could at least change the system to give more control to patients. Drugs such as statins could be subject to a “one-time prescription rule” in which consumers can purchase the medication freely after an initial consultation/sign-off from their physician. Surely that would be better than the status-quo of constant phone calls and doctor’s visits to authorize refills.

Bureaucrats would be wise to lessen controls on medications and ingredients such as pseudoephedrine and put patients in the driver’s seat. No one should have to suffer a sniffly nose (or clogged arteries) because they didn’t read up on the latest federal rules.

David Williams is the president of the Taxpayers Protection Alliance.

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  • The FDA cannot make proper policy on its own because it is almost completely unfettered from public opinion even though it claims to hold hearings for public comment. The public had a better chance of telling El Chapo what to do. The FDA and all bureaucracies need direction, a framework, such as a cohesive, long term federal policy on drugs, devoid of political whimsy and payola … and that will never happen.

  • The easiest solution is to relax the restrictions on Sudafed’s original main ingredient Pseudoephedrine. Which actually works as a nasal decongestant and then no one would even notice phenylephrine was even missing other than gaining the ability to breathe through their noses.

  • Added to the medications that should be OTC are low level doses of blood pressure medications for borderline hypertension. I take my own pressure and know when I need these drugs. Instead of leaving it to government, it’s time to trust the citizen to handle their own healthcare. Periodic Dr. visits are obviously useful but every 3 months? When my prescription expires, many times I’ll just stop taking it entirely, but if I could get it easier, that would change.

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