Despite gridlock in the House of Representatives, there are threats to public health and safety that are so compelling that basic humanity demands bipartisan action. One of those challenges is protecting our supply of essential medicines.
According to drug shortage tracking conducted by the Food and Drug Administration’s Center for Drug Evaluation and Research, drug shortages more than quadrupled between 2005 and 2011.
In response, President Obama’s 2011 Executive Order to protect the supply of drugs that are central to the treatment of cancer and other deadly diseases, together with The Food and Drug Administration Safety and Innovation Act of 2012, gave the FDA expanded authority to combat drug shortages.
These are important first steps that all Americans should applaud, whatever our political philosophies may be.
We also must also take effective corrective action to address the profiteering by some that exploits patients and our health care system alike.
As the ranking Democrat on the House Oversight and Government Reform Committee, I began investigating this issue after receiving a passionate letter from Brenda Frese, head women’s basketball coach at the University of Maryland at College Park.
Ms. Frese’s son was diagnosed with leukemia and was being treated with cytarabine, a cancer treatment drug on the FDA’s shortage list.
During our investigation, we learned that there is a large “gray market” in which unscrupulous companies buy and sell critically needed drugs at prices many times higher than typical contract prices.
In some instances, our investigation found that critical drugs had been marked up by more than 80 times their standard contract price. Some of the largest markups are for life-prolonging drugs for critically ill patients, including those, like Ms. Frese’s son, who are battling cancer.
These outrages should be seen for what they are, profiteering that is just as onerous as the abuses that occurred in the sale of scarce, but essential, goods during World War II.
As President Obama has observed, “The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety.” When “prices are being driven up because shortages are being made worse by manipulations of companies or distributors,” we need to make sure we put an end to those practices.
“This is a problem we can’t wait to fix,” he continued. “That’s why today, I am directing my administration to take steps to protect consumers from drug shortages – and I’m committed to working with Congress and industry to keep tackling this problem going forward.”
I agree with the President’s assessment and commend him for helping patients obtain lifesaving drugs in critically short supply. Without question, our federal government must address both these shortages and their economic consequences.
Although government and the pharmaceutical industry work hard to avoid shortages, the harsh and dangerous reality is that the number of reported drug shortages tripled from 61 in 2005 to 178 in 2010.
One significant reason for this disparity is that the capacity of manufacturing facilities has not kept up with rapidly growing demand.
A related and equally dangerous challenge is raised by “gray market” drug companies that are taking advantage of the national drug shortage to charge exorbitant prices for drugs used to treat cancer and other life-threatening conditions.
The House is scheduled to take up legislation to address the entire pharmaceutical supply chain. Although it includes one provision to address these gray market actors, much more needs to be done.
This is why I have introduced legislation that would sharply limit the ability of profiteers to exploit drug shortages. The Gray Market Drug Reform and Transparency Act of 2013 (H.R. 1958) would address weaknesses in the drug supply chain, deter price gouging, and improve drug safety and efficacy.
It would prohibit wholesalers from purchasing drugs from pharmacies, a practice that has been abused by unscrupulous wholesalers to obtain access to shortage drugs, charge excessive markups, and divert drugs away from patients who need them.
It also would strengthen oversight and transparency by creating a national, publicly available database of information on distributors that includes information on their licensing status and disciplinary actions.
Nobody should be allowed to profiteer at the expense of children and adults with cancer or other critical illnesses by jacking up the price of drugs that are in critically short supply.
If we are to overcome this challenge in a permanent, long-term way, there are many issues that must be resolved in practical and bipartisan ways.
I am hopeful that my colleagues in both parties will agree.
The public’s safety, not ideology, should govern when the availability of essential medicines is threatened. A responsible government must take action when human life is at stake.
Congressman Elijah Cummings represents Maryland’s Seventh Congressional District in the U.S. House.
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