This past year there was a pharmacy compounding tragedy that is now being used to kill personalized medicine. You may remember the NECC pharmacy catastrophe where contaminated samples of steroid were sent to various hospitals and surgery centers. Unsuspecting doctors then injected this medication while performing epidural steroid injections. This unfortunate event has caused a knee jerk reaction to give the FDA unprecedented new powers to control the practice of pharmacy and block the development of the nascent personalized medicine movement. You likely don’t know the backstory on this event, so let me explain.
Last year there was a national shortage of many drugs. For example, our clinic had a hard time buying local anesthetics. While we don’t use high dose steroids very often, they were also in very short supply. Why? The FDA had begun to increase it’s inspections of the drug factories that make these inexpensive generic drugs. While few credible safety issues were identified, many of these factories closed to address a laundry list of minutia that had to be addressed if they wanted to continue to operate. As a result, the only place many clinics and hospitals could get these drugs were compounding pharmacies. Hence this was the reason many clinics in the Northeast were buying much more expensive compounded medications from NECC rather than buying much cheaper generics off the shelf. So a problem caused by increased FDA inspections led to a marked increase in the use of compounding pharmacies to fill the gap.
Compounding is a time honored tradition of tailoring medications to fit the patient. At it’s simplest, it’s when a known drug is taken from pill form and put into a flavored liquid for a pediatric patient. However, over the last 15 years, a number of pharmacies have turned this into a huge business. They in effect became mini drug factories. This has caused a public health dilemma. For example, a small pharmacy is only regulated on the state level and if it does bad things, it can only cause harm to the people in it’s local community. However, when some of the compounders turned into national operations, sending compounded medications all over the country, they took on the risk profile of a drug manufacturer. Hence, when the NECC tragedy occurred, it wasn’t a local problem impacting the few local clinics that performed epidural steroid injections, it was a national problem as these steroids had been shipped all over the nation. In other words, it became FDA’s problem. In my mind, there is little doubt that we do need more regulation on pharmacies that decide they want to sell drugs nationally. To address this issue, senator Harkin created Senate Bill 959. If all 959 did was to place tighter sterility restrictions on these national compounding pharmacies, it would be a net positive for everybody. However, the author of SB 959 went much further.
The FDA has been trying to get it’s arms around pharmacy compounding since at least the 90s. Back then it took it upon itself to write regulations for pharmacists that compound medications. There was just one problem, congress never granted it the authority over pharmacies which are instead regulated by the states. So a number of pharmacies sued the FDA and the agency lost at all court levels. In fact, this section of the FDA regulations was literally erased by a federal judge and remains blank to this day. Why would the FDA care, especially when back then there was no NECC tragedy on which to hang its hat? Compounding reduces the sale of FDA approved drugs by acting as an alternate drug delivery pathway. In fact, as discussed above, it’s a safety net for when the FDA approved drugs don’t work or are in short supply. In addition, it promotes the concept of off-label drug use by physicians. Off-label means that a doctor is thinking outside the box and invents a new use for a medication other than the one the FDA has approved. The agency has no love for off-label use, in fact they sued a physician in the 70s who was routinely prescribing off-label. The case (U.S. v. Evers-453 F. Supp. 1141 (M.D. Ala. 1978)) was a landmark decision that affirmed that doctors could and should think for themselves when treating patients. The Court reasoned that a drug’s approved use may not be the most up-to-date information on the drug’s uses and that new uses are often discovered, reported through medical journals or seminars, and may become widely used in the medical profession; however, the drug manufacturer may not have sufficient financial or other interests to pursue FDA approval for the new uses. Further, if a doctor must prescribe and treat only within “federally sanctioned” methods, this would result in medical stagnation at best, as physicians await drug manufacturers’ initiative and FDA approval. The court reasoned, “A free, progressive society has an enormous stake in recognizing and protecting this right of the physician.” Basically, the court preserved as sacred the right of your doctor to prescribe any drug in any way to save your life or treat your illness.
So what’s in SB 959 that’s a problem? One of the glaring issues is a “gimme” for Pharma; a prohibition on compounding a drug if there is already a form that’s FDA approved. So to use an example, if SB 959 had been in force when the FDA shuttered drug factories and the national supply of anesthetic and steroid had dwindled, doctors and hospitals would have had to turn patients away. In addition, several stories have also pointed out that there is also still a shortage of pediatric cancer drugs, so these kids would have had to be left without treatment as an alternate source of the medication is often the hospital pharmacy compounding the cancer drug. Another unintended consequence of this new regulation is the practice of raping and pillaging patients for low cost generics because some pharma company decided to place a grandfathered approved drug through a modem FDA approval. A great example of this is synthetic progesterone (17P), a drug commonly used to prevent premature birth. It costs about $300 to compound. However, the generic drug manufacturer KV pharmaceuticals put it through an FDA approval process and upped the price to a staggering $30,000! Getting 17p at the more affordable price would be illegal if SB 959 passes.
In addition to allowing Pharma to rack up crazy profits by selling “FDA Approved” drugs that are supposed to be cheap generics, there are other issues with SB 959. It generally makes compounded medications harder to get. This is a huge problem for the nascent personalized medicine movement. There’s now a small army of physicians who aren’t happy with the Pharma controlled status quo in medicine. They innovate and find new uses for medications and try unique combinations of them to help patients. This fits like a square peg into the FDAs round hole of regulations. For example, our FDA drug approval process was created in 1962, when color TV was a hot idea. It’s designed to find one size fits all solutions for patients that we now know are genetically different. The personalized medicine movement is beginning to look at these genetic differences and only use medications in combinations and forms that an individual patient can tolerate. To the FDA this is blasphemy, as it doesn’t even have a category for this type of personalized care. In addition, this type of personalized medicine is out of sync with today’s national health policy. For instance, the entire cost saving premise of ObamaCare is to place government panels in charge of medical decision making so that one sized fits all medicine can be legislated to the masses (these panels will decide the treatment guidelines that doctors must adhere to if they are to be paid more by Medicare). All of this is great for Pharma and for FDA as the agency now earns 2/3’rds of it’s drug approval budget through PDUFA fees paid by Pharma companies (like KV Pharmaceuticals) for drug approval applications. For patients who understand that they’re not like the guy down the street, but a unique individual who might need personalized care, it’s a disaster in the making.
The upshot? SB 959 started out with a good premise-place stricter controls on pharmacies that have become mini-pharma companies. However, the FDA has wanted to stamp out pharmacy compounding and physician outside the box thinking since at least the late 70s and isn’t letting a tragedy go to waste. Please contact your senator and congressman now and tell them to oppose SB 959 and the FDAs power grab. Click here to speak out to your representatives.