I posted a few months ago about prescription drug shortages and opportunistic price gouging, and wondered then, what—if anything—can be done about the situation. That topic is on my mind again, because as was reported on SecuringPharma, the U.S. Food and Drug Administration (FDA) has recently warned healthcare providers to be vigilant when sourcing injectable cancer medicines. Current shortages could encourage what the FDA terms, “unscrupulous individuals,” to introduce unapproved and potentially counterfeit drugs into the supply chain.
The problem with price gouging is that some generic drugmakers decide to quit making certain drugs because they offer little profit. When the maker of a particular generic drug suddenly stops producing it, other companies typically don’t have enough capacity or time to make up the shortfall before the stoppage begins to effect patients. There also always is the possibility of manufacturing-quality problems that cause drugmakers to temporarily shut down production. When either of those situations occur, some middle-men are quick to take advantage of the shortage by purchasing the available supply and then raising the price by incredible amounts.
While cost is a considerable issue, the more significant concern is that drugs offered on the gray market also pose a safety concern. The gray market operates outside the tightly controlled pharmaceutical distribution channel, where strict standards for storage and handling are enforced, as well as requirements to record the product’s chain of custody. Furthermore, there typically are narrow ranges of temperature and climate conditions required to maintain drug efficacy, and only a tightly controlled supply chain channel can meet these requirements. Failure to handle and store drugs properly may cause them to become inadequate, and in some cases, potentially harmful.
This latest development concerning injectable cancer medications also is disturbing. The FDA notice says that current shortages of injectable cancer medications may present an opportunity for individuals to introduce non-FDA approved products into the drug supply, which could result in serious harm to patients. The FDA reminds health care providers to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the U.S.
The disturbing part is that the FDA is aware of promotions and sales of unapproved injectable cancer medications direct-to-clinics in the U.S.—and that they most likely were administered to patients. According to the administration, products purchased include a high percentage of sterile injectable medications and medications whose quality could be adversely effected if they are not stored or transported under specific temperatures.
In these cases, patients were unknowingly placed at risk when they received medications of uncertain purity, storage, handling, identity, and sourcing. That’s because any medication that has not been manufactured in accordance with FDA standards and pursuant to FDA approval—including foreign versions of FDA-approved medications—is considered unapproved. Although the FDA recommends that, in an effort to protect the health of patients, health care providers should use only FDA-approved versions of these cancer medications. However, it’s readily apparent that does not always happen.
What’s interesting is that in certain circumstances, the FDA may authorize limited importation of medications that are in short supply—but it seems that isn’t happening. These medications are imported from approved international sources and distributed in the U.S. through a controlled network, and would not be sold in direct-to-clinic solicitations. If the FDA has arranged for limited importation of the foreign version of a medication, information on obtaining that medication will be available on the FDA drug shortages website, often in the form of a “Dear Healthcare Professional,” letter.
So obviously, there is a problem with the system here where demand far outstrips supply. Some would argue that the solution is to give the FDA more “teeth,” or authority to crack down. However, I’m not sure how well that approach would work.
What about you? What do you think?