To Big Pharma, Compounders Are A Grind
2 CommentsBy Ed Silverman // March 27th, 2007 // 4:02 pm
Drugmakers are backing a bill being drafted by Ted Kennedy and two Republican senators to give the FDA more authority over compounders. Supporters say this would prevent compounders from becoming de facto drugmakers turning out large quantities of meds that, in some cases, may hurt patients. State pharmacy boards currently oversee the thousands of compounding pharmacies.
For instance, AstraZeneca, which makes an asthma drug, is working with the Allergy & Asthma Network of Mothers of Asthmatics, whose chairperson is an AstraZeneca employee, Pamela Mason. The group says some pharmacies fill prescriptions using store-made compounds without informing parents, exacerbating their children’s asthma symptoms.
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, which is sending blast e-mails. “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.
Opposing the bill are groups such as the International Academy of Compounding Pharmacists, which argue the measure would rob patients of medicines that may have been discontinued, contain an ingredient not easily tolerated or isn’t available in a particular dosage.
Among their objections: a requirement for doctors to document the need for prescribed compounds, new restrictions on the use of injectable compounded meds in doctors’ offices, and mandatory labeling stipulating compounds don’t meet FDA manufacturing standards.
A GOP aide says the challenge is to produce an effective stand-alone bill that balances the competing interests in the fight — and to pass it, if possible, in time for the August recess, without dragging the bigger FDA user-fee legislation into the picture. “We need to make it harder for compounders to sell their products in a mass way,” says the aide.
You can read…
the full story in Congressional Quarterly (registration required);
Statement from the International Academy of Compounding Pharmacists.
The Allergy & Asthma Network of Mothers of Asthmatics.
[tags]Allergy & Astham Network of Mothers of Asthmatics, AstraZeneca, Consumer Health Alliance for Safe Medication, International Association of Compounding Pharmacies, PhRMA, Ted Kennedy[/tags]
Karen
This whole contoversy has nothing to do with public safety. The only thing that this is about is MONEY. If compounding pharmacy did not affect Wyeth’s bottom line then we would not even have an issue to debate. Before Wyeth and the rest of “Big-Pharma” existed, compounding was the only source of pharmaceuticals. The history of pharmacy started with compounding. Is Sen. Kennedy going to attempt to erase history?
Nancy
As long as laws do not clearly distinguish between the public health service of traditional compounding and the public health and liability risks of mass manufacturing under the guise of traditional compounding, patients and the public will suffer.
All drugs have risks. The more you know about a drug, the more likely you will be able to use it to your benefit and minimize unwanted side effects. Patients know more about FDA-approvd medications than they do about compounded medications because federal law requires labeling to identify risks, warnings, chemical structure, inactive and active ingredients, instructions for use, etc. The products are identified by date of manufacturing, expiration date, lot numbers, etc.
We don’t know as much about compounded medications that are made especially for us. We know even less about mass manufactured medications that were mixed under the guise of compounding. Labeling requirements vary from state to state but of the hundreds of samples we’ve acquired from patients, labeling was either nonexistent or incorrect or applied to the vial in such a way that ink and adhesive chemicals would pass through the vial into the mixture. We found ethanol and benzalkonium chloride, chemicals that cannot be used in FDA-approved products, and bacteria known to cause pneumonia in some vials.
But none of these medications were compounded; they were mass manufactured under the guise of compounding. There is a huge distinction. One is legal and the other is not.
When a physician and patient determine that FDA-approved medications are incapable of resolving a unique medical need, they can turn to a compounding pharmacist who will become part of the medical care team. This person will work with both the patient and the prescriber to find the right medication, dose and delivery system and then follow the progress of the patient. This is what specialty customized traditional compounding involves.
But increasingly, patients and their caregivers are discovering that the definition of compounding has been expanded to include mass manufacturing. For example, FDA warning letters were sent to Lincare/Reliant, Rotech/Pulmidose, and CCS Medical who were making millions of doses of illegally mass manufactured nebulizer medications. Cases reported to FDA by Allergy & Asthma Network Mothers of Asthmatics by patients and physicians told us their prescriptions for FDA-approved nebulizer medications had been filled with something other than what they expected. Pharmacists told them their products were generic or better than the FDA-approved medications because it was made especially for them.
These patients included children, adults and elderly who simply needed medications to breathe. They did not have some unique otherwise unmet need. They did not recall requesting the pharmacy manufactured products they received.
The companies said they were compounding but the evidence showed they were making copies of FDA-approved medications. Rotech said they’d stop making the drug but at a cost of $28 million.
Eight other businesses received FDA warning letters or their businesses were raided. All were members of the International Academy of Compounding Pharmacists, an association formed by bulk chemical suppliers and business marketing firms to serve the growing number of pharmacists entering the “compunding” business. IACP is also responsible for launching campaigns against those who support Senator Kennedy’s discussion draft, Safe Drug Compounding Act of 2007.
Five years ago, Signature Compounding Pharmacy owners started their business with $300,000 dollars and when arrested last month along with a dozen others, they’d grown a $40 million operation.
That’s just one example!
One of the most consistent tactics used by IACP is to point fingers of shame at big PHrMA, FDA, Congress, and those of us genuine nonprofit organizations and medical associations that oppose them. What is so difficult to understand. We want to protect patient access to traditionally compounded medications. We don’t want it to be diluted by mass manufacturing under the guise of compounding.
If it is not possible to compound a drug safely in a small batch for one patient, purchasing manufacturing equipment and mass manufacturing it is not a safe alternative, particularly in absence of meeting federal requirements to be FDA registered and inspected and proper filing to make the drug under law.
Rather than focus on “big PHrMA” or “The Government” or “Congress” or some other conspiracy theory, IACP should consider that sick people want to be able to trust their pharmacists as part of their medical team. They should be able to trust that our medications are FDA-uproved unless we request an unapproved drug and it is labeled as such. It is the exceptional patient that requires a compounded medication, not the masses.
We asked for legislation that would require a simple label that says, This compounded medication is not FDA-approved. IACP objected saying that it would cause patients to have a “nocebo” reaction…that if patients know the medication is not FDA-approved, they may think it doesn’t work as well.
Hmm. IACP doesn’t want patients to know that their compounded medications are not FDA-approved. What else don’t they want us to know? Things like clean room conditions vary from one pharmacy to the next, that “rent-a-pharmacy” suites and manufacturing operations will mix just about any combination of medication in any quantity on their assembly line equipment all the while promoting their products to patients and physicians as if they were compounding specifically for “YOU”.
They don’t want us to know that their “compounding/unregulated pharmacy manufacturing” is a $2.1 Billion, yes Billion, dollar industry (reported in 2005). IACP claims to have raised more than $6 million since 2005 to hire two lobbying firms, a public relations firm, an image consultant and legal teams to launch and maintain a campaign to discredit and fight patient and physician groups who have been victimized by their members.
We asked for legislation that would protect the art and science of traditional compounding and differentiate it from mass manufacturing. IACP says volume doesn’t matter - it’s still compounding. We say, if the batch of drugs is made for more than one person, it is not compounded specifcally for that person. Advertising should not lead patients to believe that they are getting a compounded drug when in deed they are getting one that was manufactured in a facility that is not registered with FDA and not inspected by FDA.
IACP says that keeping records of patients who need compounded medications would be too great a burden for the pharmacist. They don’t want to have to report adverse events and they don’t want to be subject to reporting interstate transactions.
We’ve gone through the reporting process with enough patients now to know that your rights and access to information is basically, well, non existent.
For pharmacists engaged in mass manufacturing, the volume of patients is so great, they are unable or unwilling to purchase the software necessary to maintain patient records.
Those who are compounding for a single patient and involved in the treatment plan as is the case in traditional compounding, keeping records would not be a burden, it would be a public health benefit. It is also a way for the pharmacist to minimize liability risks.
Reporting adverse events provides information that can help prevent similar experiences in other patietns using traditionally compounded medications.
As to interstate commerce, there are numerous states that issue more licenses to pharmacies located in other states than to pharmacies in their own states. It is not possible for state pharmacy inspectors to inspect out of state mail-order pharmacies. In stead, they rely on the laws of the state where the pharmacy is located to ensure that the medications reaching patients in another state were mixed in an appropriate manner.
This type of monitoring is not happening consistently. Some state pharmacy boards are sympathetic to our cause while others turn a deaf ear to patients’ reports of fraud and abuse.
The history of pharmacy may have started with compounding one prescription for one patient at a time, but FDA was formed by the United States Congress 100 years ago to protect America’s food and drug supply from snake oil salesmen and those who would mass manufacture medications without proof of safety, effectivenes, sterility or therapeutic equivalency. Sadly, FDA is woefully underfunded and enforcement is not what it should be.
That’s why we need strong laws to protect the science and art of traditional compounding and to eliminate mass manufacturing under the guise of compounding. If a pharmacy wants to become a small pharmacuetical manufacturer, there are legal and safe ways of doing this. By the way, that’s how most big pharmaceutical companies got their start.
The clock is ticking for those engaged in llegal mass manufacturing. The more nervous they become, the more dramatic and urgent their pleas become for their patients, their piggy banks, to tell Congress “Don’t take my compounded medications away.”
The sky is not falling and it is shameful that IACP’s website and their member websites, their pharmacy on-hold messages, posters and post card campaigns frighten people into calling and writing congressional staff making demands that they stop doing something that they are not doing in the first place. My best advice to all Americans is to get to know the issue well enough to be certain that the demands you make will get you the result you want.
Don’t buy into IACP’s scare tactics. The Safe Drug Act of 2007, was a discussion draft. People were invited to write comments and look for ways to protect the science and art of compounding. Why should any honest pharmacist and/or pharmacy association be afraid of this? Let’s all work to do what is right for the patient, because nothing else matters.
Nancy Sander
President
Allergy & Asthma Network
Mothers of Asthmatics
http://www.breatherville.org/CHASM to learn more