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COMPOUNDING UNDER ATTACK
I received the following communiqué from the International Academy of Compounding Pharmacists on March 27, 2007. It is clear that Big-Pharma has rallied their forces - and their financial clout - and they're taking direct aim at compounding pharmacists. This time they've enlisted the aid of some big political hitters. I feel that I constantly imposing on my readers with this same topic. I'm sorry for this intrusion, but I fear for my future and for those our pharmacy serves.

Read Larry's Comments

Congressional Quarterly reported March 26, 2007 that pharmaceutical companies are in “high lobbying mode” to support the Kennedy legislation to shift control of pharmacy compounding to FDA. The article reports:
Big pharmaceutical companies have joined forces with aggrieved families of patients who allege they’ve been harmed by hand-mixed medicines . . . to push for the passage of a bill currently being drafted by [Senator] Kennedy of Massachusetts . . .
State pharmacy boards currently oversee the thousands of pharmacies that make compounds. Kennedy’s plan would shift primary oversight to Washington . . . Bigger drug manufacturers counter that compound makers are exploiting their regulatory exemption for profit. “They’re basically making bulk quantities and selling them to doctors at a discount,” says Eamonn P. Hobbs, whose company, AngioDynamics, manufactures treatments for varicose veins.

Companies such as AstraZeneca, which makes a drug for asthmatics, are teaming up with an activist group called the Allergy & Asthma Network Mothers of Asthmatics to press for the Kennedy bill. The mothers say that some pharmacies filled prescriptions using store-made compounds without informing parents, exacerbating their children’s asthma symptoms.

Bill supporters are in high lobbying mode. The mothers group has created a 12-organization coalition, the Consumer Health Alliance for Safe Medication, supported in part by drug companies and patient groups, and it is already sending blasts of e-mail to it [sic] supporters. “If you don’t contact your senator TODAY,” one reads, “businesses who make a living giving patients potentially harmful medications will make sure this legislation never makes it to a vote!”

The alliance plans to hold a three-day forum in Washington starting April 30 that kicks off with a session including an update on their advocacy campaign. Pharmacists, meanwhile, plan to devote their July fly-in to Capitol Hill to lobbying their side of the issue — and reminding legislators that existing laws and regulations effectively curb abuses.

Drug companies want bright-line language in the bill to stem any pharmacy-based manufacturing of drugs. “When a pharmacy is compounding a product, it should be because there’s no commercially available product,” says Marjorie Powell, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America. The group also wants to ban compounders from using ingredients withdrawn from commercial medicine uses and to ensure that they work in sterile environments. . .

ACT NOW
The Senate is in recess next week, April 2-6. Set up an appointment to visit your Senator in his or her district office (enter your zip code at http://www.congress.org to obtain contact information for your members of Congress). The following Senators are on the HELP committee that has jurisdiction for this legislation:

Edward Kennedy (Mass.)
Christopher Dodd (Conn.)
Tom Harkin (Iowa)
Barbara A. Mikulski (Md.)
Jeff Bingaman (N.M.)
Patty Murray (Wash.)
Jack Reed (R.I.)
Hillary Rodham Clinton (N.Y.)
Barack Obama (Ill.)
Bernard Sanders (I) (Vt.)
Sherrod Brown (Ohio)
Michael B. Enzi (Wyo.)
Judd Gregg (N.H.)
Lamar Alexander (Tenn.)
Richard Burr (N.C.)
Johnny Isakson (Ga.)
Lisa Murkowski (Ark.)
Orrin G. Hatch (Utah)
Pat Roberts (Kan.)
Wayne Allard (Colo.)
Tom Coburn, M.D. (Okla.)


Larry's Comments

Compounders have won numerous decisions in the courts (even the U.S. Supreme Court) and many smaller battles. When Wyeth petitioned the FDA to interfere with compounders' preparation of bioidentical hormones over 55,000 comments were filed with the FDA - in support of compounding pharmacists.

The AMA passed a resolution a few months ago, siding with the drug makers. They again wanted the FDA to "do something" about compounders. And, people from all across the land voiced their opinion.

This latest assault is being spearheaded by Senator Edward Kennedy. I guess the courts and public opinion weren't good enough for our adversaries. Those who want us out of the way have taken their ideas and their dollars to he highest levels of politics. If they can't destroy us through the courts and the government agencies, perhaps they will be more successful using politics and legislation. This is a dangerous path to take.

Compounding is a time-tested process and vast numbers of commercial drug products had their humble beginnings at the hand of a skilled compounding pharmacist. The safety numbers for compounding are staggering.

Those behind this recent attack are convinced that Federal regulations are the best protection available for the American public. These are the same kind of regulations that allowed the wide distribution of Vioxx (it was removed from the market and then allowed back after several months). States have always been responsible for regulating the activities of pharmacies within their borders. This recent effort, then, is an effort to impede States Rights and replace them with more central power.

This isn't about safety or good medicine. It's about money, politics, and States Rights. If the money handlers and drug makers are successful with this effort where do you suppose it will end?

Some people fear large centralized governments. I do. Our founding fathers knew the dangers and created a government that was supposed to avoid the pitfalls common to large central governing bodies. Over the years those original thoughts have been eroded. The attack on our freedoms will not stop with the destruction of the way pharmacy is practiced. Who knows who will be the next target.

Please lend a hand to protect pharmacy.

Here's a link to a place where you can join this effort.

Thank you

Larry

 

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