Antibiotics Development Down, Congress, FDA Catch Up


The restaurant chain McDonald's March 4 decision to address the problem of drug resistance deserves attention but still leaves a less-than-robust antibiotics pipeline that stakeholders have to work hard to correct, a noted economist told me.

Paul H. Rubin, professor of economics at Emory College of Arts and Sciences, told me in a phone interview, "Fighting drug resistance, is important. But McDonald's decision to buy only chickens not treated with human antibiotics gets the back-pat, and people don't think about the supply side of antibiotics, which is crucial. The U.S. government, over the years and unintentionally, made it difficult to get new antibiotics to market."

He was alluding to  the Food and Drug Administration's decision a decade ago to increase the number of subjects required for antibiotics clinical trials and its efforts to combat drug resistance. Rubin wrote in a widely-quoted  2004 article that decisions such as these have had the effect of making antibiotics less profitable for biopharmaceutical companies and caused many of them to move out of antibiotics development. "Government is  trying to catch-up, but it needs big incentives to do so," he said.

Antibiotics and Their Makers Decline. The number of new antibiotics coming on the market has declined: 16 were approved from 1983 to 1987 but just two from 2008 to 2012, according to a study published in the journal Clinical Infectious Diseases.  And fewer companies are developing antibiotics.  Karen Bush, a professor of biology at Indiana University, told me in a March 12 e-mail that there were 36 large pharmaceutical companies conducting antibacterial research in 1980 and that that number dropped down to 20  in 1988. In 2015, she wrote, there are six: The Medicines Company; GlaxoSmithKline; Merck-SheringPlough-Cubist; Novartis; Roche; and Sanofi-Aventis.

One of the reasons for this decline is that antibiotics make less money than other drugs, which biopharma execs confirmed for me. "They're a one-event deal as opposed to drugs that you take every day for the rest of your life for your cholesterol or thyroid or to treat a particular disease," Rubin said.

Congress, FDA Work to Fix. But Congress and the FDA has responded to the lack of new antibiotic development. The Generating Antibiotic Incentives Now (GAIN) Act, which was enacted as part of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, created incentives for biopharmaceutical companies to come up with new antibiotics, including faster review and extended protection from generic competition. Biopharma researchers have told me that the FDA has reworked almost all of its antibiotics guidances in order to move antibiotics applications forward and has reduced a number of the studies required from two to one. This sense of a movement forward is why their companies have stayed in the antibiotics area, they said.

 

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