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.

CMPI

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.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog