Associate Editor and Assistant Professor at the University of Maryland School of Pharmacy Peter Doshi, like many academics, comments academically because the real world is a simple black box - he believes authorities should not be approving drugs unless they are certain they can tackle the problem of antimicrobial resistance.
The FDA has responded to the corporate sector's desire to give up on low-margin products and focus on 'home runs' by offering marketing incentives for new antibiotics, not recognizing that the increased thresholds and bureaucracy have led to high costs, not a lack of intellectual firepower. Backed by a law passed by Congress in 2012, 61 chemical entities have been granted "qualified infectious disease product" (QIDP) status, promising accelerated review of new drug applications and five additional years of marketing exclusivity.
The FDA considers a QIDP product "an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections and does not have to show added benefit in terms of efficacy."
Doshi objects to approving a new drug unless it showed added benefit. He points out that three of the five new antibiotics were approved for skin infections, yet there are already over 30 other drugs approved for these conditions, including treatment for MRSA infections.
The actual experts who make products and the Infectious Diseases Society of America (IDSA) argue that the new drugs are tackling the problem of antimicrobial resistance, pointing to the fact that the drugs are approved to treat MRSA infections.
"While the FDA celebrates new drugs approved under the GAIN Act, there remains no evidence the drugs meet unmet medical need, address antimicrobial resistance, or are more effective than pre-existing antibiotics," writes Doshi.
The United States Congress disagrees and in January a new bill was introduced - the Promise for Antibiotics and Therapeutics for Health (PATH) Act. The bill proposes lowering the requirements for FDA approval of new antibiotics that target unmet medical needs in specific, limited populations of patients.
Proponents argue these changes are necessary to study rare but important pathogens, but Doshi disagrees and says that "the evidentiary standards set forth in PATH suggest that future patients will be offered drugs with very limited evidence of efficacy."
An accompanying commentary by Diana Zuckerman, president of the National Center for Health Research in Washington DC, and Gregg Gonsalves, lecturer in law at Yale University, warns that new legislation to further speed the drug approval process while further weakening the standards for safety and efficacy is "a trade-off with potentially deadly consequences."
The president disagrees, that is why he fast-tracked money and promised rapid approval for an Ebola vaccine.
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