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In the cover story of this issue of OSN, we tackle the conundrum of compounding pharmacies. To put it simply, the problem is that patient safety always comes first, but access to unapproved drugs is sometimes vital to saving lives, or at least eyes.
So how did we get to this place of conflict? At the center of the conflict is the extraordinarily high cost of getting drugs approved by the FDA. While improvements have been made, the process takes years and up to $2.6 billion per drug, according to a Tufts University 2014 study. And when the FDA approves a product, it is for a limited route of administration and intended use. For example, topical antibiotic eye drops are most commonly prescribed in the U.S. for preventing surgical infections, but they are approved instead for treating bacterial conjunctivitis. At least we have access to these drugs and can prescribe them off label. But what about much-needed medications like fortified antibiotics for corneal ulcers and preservative-free glaucoma medications, of which a limited number are sold as approved products. Previously, we could get these medications easily through local compounding pharmacies. Availability has become much more limited and costs higher since the Drug Quality and Security Act of 2013, which brought much stricter federal regulation of outsourcing pharmacies. This has put many compounders out of business and sent doctors, often unsuccessfully, scrambling to find new sources of these needed medications.
I see two ways to address these problems:
1. The FDA needs to ease further the process of new drug approvals. This will open the pathway for safe access to a variety of new formulations and combinations of drugs. Fast-tracking the process for products already approved in other therapeutic categories or formulations will save costs and bureaucracy, and make drugs more affordable at the point of sale. More products mean more competition, and this will generally drive prices of existing products down further. And easing the approval process will fuel innovation and investment in new ideas that arise daily as big data give us new insights on treating disease. We simply can’t expect any company to bring a new drug to market at a cost of $2.6 billion.
2. We need to more tightly regulate the sale of “me-too” drugs sold by compounders that undercut the proper approval process. Selling a single bottle containing a mixture of moxifloxacin, prednisolone acetate and ketorolac is an extremely appealing alternative to prescribing three bottles of medicine for cataract surgery. Isn’t it unfair competition, though, with manufacturers who paid billions to get each drug approved, are required to sell each product separately, and can’t possibly get a combination drug approved for commercial sale? If instead these combination drugs were easier to approve, there would be no market for compounding pharmacies to use loopholes to skirt the FDA approval process.
To be sure, compounding pharmacies will always provide a much-needed service; there will always be oddball drugs that are otherwise not available. Our patients are best served if compounding pharmacies’ work is limited to the unusual condition that falls between the cracks. Drugs with broader demand will serve patients best if they are available in a wide variety of forms through a streamlined approval process undertaken by medication manufacturers who best understand the drug safety business.
Disclosure: Hovanesian reports he is a consultant to a variety of health care companies, including pharmaceutical manufacturers.