SADANAND: The drug shortage crisis requires intervention

As the 2012 presidential campaign continues, we’ll only hear more and more repetitive statements about healthcare coverage plans. Lost in the partisan debate about Romney-care vs. Obama-care is a very immediate health concern: drug availability. As of last summer, almost two hundred drugs crucial for treating infections and several types of cancer were in limited supply. This is a record drug shortage, and the situation is so critical that President Obama issued an executive order in October to give the Food and Drug Administration more power to report drug shortages and drug price gouging, as well as fast-tracking drug production applications.

Unfortunately, this action was insufficient to alleviate major drug shortages, and several pieces of similar legislation have not made it through the Senate. Last week, the FDA revealed that hospitals might run out of methotrexate — a drug used to treat rheumatoid arthritis and childhood leukemia — within two weeks. For both arthritis and leukemia, methotrexate must be taken on a frequent basis in order to be effective. An interruption in supply will cripple the effectiveness of the drug. While there are several alternate medications for arthritis, methotrexate — like many of the other drugs that are in limited supply — is essential to treating childhood leukemia.

There are several causes of drug shortages. Often plants have to be closed due to concerns about contamination, since contaminated drugs would be especially dangerous to cancer patients, who have particularly vulnerable immune systems. Many companies outsource production to international plants where labor is cheaper and quality control is less stringently enforced. While this enhances the profit margin, patients in the U.S. are stuck because the drugs often lack proper clearance for import. Some plants lack the infrastructure required to mass produce drugs. Finally, drug production is controlled by just a few companies. For example, there are now only four American producers of methotrexate, meaning that when one company stops producing a particular drug it can have large implications for the entire market. With demand consistently high and supply low, the prices for many limited-supply drugs have skyrocketed — and insurance plans may not cover alternative treatments, or the alternative treatments may be sub-par.

Both parties claim to want to alleviate the drug shortage but, unsurprisingly, the blame game has already started. Predictably, Republicans are not keen on government intervention, but it is clear that the administration’s executive order does not go far enough. While it makes it easier for the FDA to identify future shortages, it does not provide any strategies for actually alleviating existing shortages. Republicans and fellow free market champions bemoan regulations as the death of business, but it is absolutely essential that the FDA continue to rigorously scrutinize plants — contamination could be deadly. Constant vigilance can help prevent costly plant closures ahead of time by having them maintain health standards.

The drug industry has agreed to invest millions in improved quality control at foreign plants. While this would be helpful, in the long-term, the government should find sustainable ways to incentivize efficient drug production in the United States. Perhaps financial incentives can be provided to pharmaceutical companies for research into improved production strategies. The number of cancer patients per year that require a given drug is fairly predictable; given this, perhaps the government could mandate that manufacturers produce a certain number of drugs yearly or face penalties. In the short-term, the government should invest in stockpiling essential cancer and chronic illness medications — that is, those for which there are no suitable alternatives. Drug companies that participate in this stockpiling could be reimbursed for their efforts, with perhaps an additional financial reward for their public service. At the end of the day, helping critically and chronically ill Americans should not be left to the whims of the free market. The president and Congress can and should do more to end the drug shortage.

Saheli Sadanand is a fifth-year graduate student in the Department of Immunobiology. Contact her at saheli.sadanand@yale.edu.

Comments