Drug Shortages and Legislative Solutions

Cancer patients, and patients with a wide range of other ailments, may not be receiving the best possible medicine because the required drugs are in shortage.  The prescription drug market is consistently afflicted with shortages, both minor and major.  Each shortage can affect one particular drug, or a range of drugs within a class.  In 2011, the United States experienced 251 drug shortages. In the same year, 183 (nearly 75%) of these shortages were of sterile injectable drugs, most commonly used for cancer treatments.  (FDA Factsheet)  Doctors do not have the option to prescribe the drugs they believe to work best because they are unavailable.  (The New York Times)

Manufacturing costs are a major contributor to the problem.  Sterile injectable drugs are very costly to make, and thus not many companies are willing to take the risk of setting up facilities to make them.  Further, the facilities that make such medicines are subject to many regulatory rules, including caps on drug prices. This means that, even when there is strong market demand for more product, manufacturers may not be able to afford to produce them, Plainly said, these drugs do not become more expensive when supply is at issue, as they might in an unregulated market, they become scarce. The manufacturing web is so fragile that a certain factory closing can extend a shortage for several months or even years.  (Medscape)

The prescription drug market is “characterized by sporadic shortages of individual drugs and occasional periods during which many drugs in a class are in shortage,” and few legislative or regulatory solutions have made a difference in solving the problem.  (ASPE Brief)  The Food and Drug Administration (FDA) takes measures to prevent and solve these shortages, which include working closely with drug manufacturers to help restore availability and working with other potential manufacturers to encourage them  to increase production to prevent future shortages.  (FDA.gov)  Unfortunately for FDA, its power is limited, and legislative response to this problem has been insufficient.

In 2012, Congress passed the Food and Drug Safety and Innovation Act of 2012 (FDASIA).  Title X of that Act is committed to the issue of drug shortages, and, in part, requires that manufacturers give the FDA prior notification when a shortage is predicted.  Other requirements laid out in Title X include allowances for expedited FDA review of drugs that may help alleviate a shortage, creating an FDA task force dedicated to the issue of shortages, maintaining a drug shortages list, agency analysis of manufacturing quotas (including the ability to change the quotas if a particular drug seems likely to be in shortage), and allowances for hospital repackaging of drugs so that they may be distributed in a more efficient way.  (FDASIA 2012 Summary)

Title X puts forth ideas that could potentially solve part or all of the shortages problem, but some of these measures have flaws that make them potentially useless.  FDASIA undercuts itself often.  For example, section 506D of Title X mandates the creation of a drug shortages taskforce.  The taskforce is to create a strategic plan which should include measures to increase communication between manufacturers and FDA.  The taskforce should also ensure that the Secretary of Health and Human Services considers shortages when executing regulatory actions, considers the implications shortages have on clinical trials, and examines opportunities for more manufacturing partnerships.  Given enough time, these steps could create a useful taskforce, especially if it fosters improved communications between manufacturers and the agency regulating them. But the taskforce is simply not given the time required to become fully ingrained in the market/regulation system.  Section 506(f) is a sunset provision, meaning that the structure and purpose of the taskforce are to end exactly five years after the bill was enacted.  This means that even if it begins to succeed, the taskforce will cease its operations at the end of five years.  It has, essentially, been hobbled with “lame duck” status since the very instant it was created.  Though sunset provisions are not uncommon in legislative acts, one as short as five years does not give the taskforce much time to assert itself before losing its mandate.  Generally, sunset provisions are meant to prevent outdated laws in the far future, but here the sunset provision renders the taskforce useless in a much smaller timeframe.

Despite the other contradictory measures, at least one part of the FDASIA has been proven effective: the early notice requirement.  This requirement forces manufacturers to inform FDA if they anticipate a shortage to be imminent, and has been effective in helping to coordinate efforts to curb existing shortages or even prevent them outright.  The effectiveness of the plan can be seen in the numbers: new shortages are at the lowest they have been since 2006.  (Salon)  It is possible that, given enough time, other sections of the act will prove equally or more effective, and in the future shortages will not be as much of a burden on the medical community as they currently are.  But unless new ideas and initiatives are given more time to become effective and do their jobs, drug shortages will remain a serious problem for the medical community.

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