Generic drug shortages show no signs of abating

August 10, 2012

What has staved off even higher levels of ongoing shortages is that drugmakers are reporting potential shortages much more often and FDA is using various tactics to prevent them from becoming reality.

As of midsummer, it was not looking as if the ongoing problem of drug shortages would get much better anytime soon.

In the spring, the Food and Drug Administration (FDA) had touted the fact that new shortages were cropping up at only half of last year's rate.

But by late June, new shortages for 2012 were over 80, about the level as the year before. According to FDA figures, ongoing shortages were over 100.

Threatened shortages actually have been happening faster in the last few months, she added.

According to FDA, it has stopped more than 150 shortages since last fall.

Meanwhile, in Congress, the House Committee on Oversight and Government Reform, with its Republican leadership, issued a report in June blasting FDA for being too strenuous in its regulation of manufacturers, particularly since Commissioner Margaret Hamburg has taken office. FDA responded that the agency and the companies themselves are finding glass shards, metal, fiber, bacteria, and fungus in vials.

The Utah center's Fox commented that just counting the MedWatch reports of adverse events directly related to product quality gives an indication of what the country is facing. "That's why it's taking a long time to fix. It's because we have some pretty severe quality issues," she said.

In terms of trends taking place over past years, shortages have increased since 2006, expanding 3.8 times since then, according to the Utah center. They increased by about 27% in 2010 and again in 2011, the center's figures indicate.

More manufacturing problems

A number of people are trying to figure out why issues with manufacturing are increasing now.

FDA said through a spokesperson recently that it is "a complex problem that is largely the result of inelasticity of manufacturing capability, market forces causing reduced prices, and firms' inadequate investment in manufacturing quality."

A report issued last fall by the Assistant Secretary of Planning and Evaluation of the Department of Health and Human Services (HHS) said that shortages appear to be greatly due to an expansion in scope and volume of medications produced, because expanded capacity will take several years to build.

The expansion of products, contended the HHS report, is due to a rise in the overall volume of chemotherapy drugs used and to an unusually large number of drugs coming off patent and thus being available for the generics industry to produce.

The House committee report pointed out that the Medicare Modernization Act (MMA) has dramatically lowered the prices that Medicare pays for some generic injectables, motivating manufacturers to change the medications they produce.

In addition, the report noted, group purchasing organizations (GPO) have emerged to help hospital and clinic networks buy drugs at lower prices. That results, it said, in markets that have only a few manufacturers making each product.

Largely because of reimbursement under MMA and the GPO contracting, the committee report said, "Individual generic injectable drugs are being produced by at most three companies."

Lower reimbursement and the switching of product lines may also result in some of the quality issues FDA said it is seeing in plants, several observers said.