Early Warning System from the FDA

Minnesota Senator plans to require drug companies to warn of shortages

/ Author:  / Reviewed by: Joseph V. Madia, MD

In response to a nationwide drug shortage that is causing serious morbidity and mortality in the United States and Canada, United States Senator Amy Klobuchar (D-MN) announced that she plans to initiate legislation that would require pharmaceutical companies to notify the Food and Drug Administration (FDA) of impending shortages or cessations in production.

In a press release, Senator Klobuchar detailed her plans to introduce legislation that would allow the FDA to require pharmaceutical companies to notify them when the company is facing an impending production shortage of a drug or when they plan to cease production of a unprofitable product. The legislation would also allow the FDA to bring in the same or similar drugs from overseas pharmaceutical companies more quickly. Currently, the FDA has the power to allow foreign pharmaceuticals into the United States, but the legislation would speed up the process.

The FDA does not have the power to mandate production of any certain drugs from pharmaceutical companies.

Sen. Klobuchar stated in the press release, “We want to respect the private market, but we also need to protect the public’s health...This is a common-sense solution. It’s not too much to ask [of the pharmaceutical companies] to have an early warning system so pharmacists and physicians can prepare in advance and ensure that patients continue to receive the best care possible.”

Currently, the United States is experiencing a shortage of over 150 prescription medications, a majority of which are sterile injectable painkillers and cancer therapy drugs. The New England Journal of Medicine recently detailed the problem in an editorial stating that the problem is one of production and profitability.

Drugs that must be produced in a sterile manner for injection in a patient's bloodstream are incredibly expensive and time intensive to make, and only the largest of pharmaceutical companies have the facilities to produce them. Recent problems with

contaminated production have also resulted in massive safety recalls. In addition, once a drug loses its patent, the drug is just as expensive to make for the original maker, but the profit margin decreases considerably, leading the original drug maker to switch their production facilities to more profitable products that are still under patent.

Unfortunately for patients, the drugs in short supply are of critical importance. According to a report from the Institute of Safe Medication Practices (ISMP) which surveyed over 1,800 healthcare providers, shortage of painkillers and antibiotics have resulted in patient deaths, decreasing the supply of other drugs that are being used as alternatives for the drugs that are short, and significant impact in terms of man hours and time spent finding alternative therapies. In most cases, the survey respondents reported that they received no advance warning from manufacturers that a drug would be in short supply, no information about when it might be available again, and no direction about what might be able to be used in its place.

Senator Klobuchar hopes to change that.

Reviewed by: 
Review Date: 
January 17, 2011