Thug Regulation

  • by: |
  • 05/24/2013

When some pharmacists refused to dispense Plan B (aka, “the morning after pill”) because of their personal moral beliefs, reproductive rights advocates and the media swooped down with all guns ablaze. “Denying access!” they cried. “Abusing their state licenses!” shouted others.

And, of course, there was litigation. In Washington, U.S. District Judge Ronald Leighton ruled the Evergreen State cannot force pharmacies to sell Plan B or other emergency contraceptives, saying the state's true goal was to suppress religious objections by druggists — not to promote timely access to the medicines for people who need them.

(Washington State – as do many states -- requires pharmacies to dispense any medication for which there is a community need and to stock a representative assortment of drugs needed by their patients.)

The state argued that the requirements are legal because they apply neutrally to all medicines and pharmacies, and that they promote a government interest — the timely delivery of medicine, including Plan B, which becomes less effective as time passes.

But Leighton ruled that the state allows all sorts of business exemptions to that rule. Pharmacies can decline to stock a drug, such as certain painkillers, if it's likely to increase the risk of theft, or if it requires an inordinate amount of paperwork, or if the drug is temporarily unavailable from suppliers, among other reasons.

Not surprisingly, today the issue of the dispensing of pain medicines is front and center.  The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.

Physicians are being asked to provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed. Walgreens has also sent letters to prescribers that provide an overview of its newly revised policy on good faith dispensing of controlled substances and cites a pharmacist’s corresponding responsibility to ensure that every prescription for controlled substances is “issued for a legitimate medical purpose.”

“Overreaching!” claim some. “Second-guessing physicians!” say others.

But, unlike the Plan B debate, this isn’t an issue over morality – it’s being driven by Drug Enforcement Agency thuggery. According to the California Medical Association, the Walgreens’ policy is in response to recent investigations and actions by the DEA.

It seems the DEA, frustrated that the FDA is taking too long to decide if hydrocodone combination products should be further restricted, has decided to take matters into its own hands, strong-arming pharmacists into submission.

And, it seems, they’re taking their cue from Congress. West Virginia Senators Manchin and Rockefeller sent a letter to FDA Commissioner Margaret Hamburg earlier this month complaining that the agency is dragging its feet on “upscheduling” drugs containing hydrocodone from Schedule III to Schedule II. Such a move would bring tighter restrictions on a variety of widely used opioid drugs.

Tighter restrictions, that is, for people that really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow FDA regulations.

When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop.

The FDA is already providing thoughtful solutions that address the problem of abuse without restricting appropriate access. Recent agency decisions such as its ban on generic forms of the non-abuse-deterrent formulation of Purdue Pharma’s OxyContin show the FDA is actively involved in the fight against addiction.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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