FDA Considers Revising Drug Reimbursement Rules For New Antibiotics, Antimicrobial Drugs

In an attempt to spur the development of new antibiotics and antimicrobial drugs, federal regulators are floating a new reimbursement scheme, which could allow manufacturers to make money even when the drugs are not widely used. 

On June 12, FDA Commissioner Scott Gottlieb announced the idea at the same time the agency issued a new draft guidance (PDF) for industry on limited population pathways for antibacterial and antimicrobial drugs, proposing that they use a licensing scheme to get paid for news medications, as opposed to being reimbursed on a per-pill basis.

At issue is pitting the concern over the overuse of antibiotics, which has resulted in efforts to decrease use of the drugs due to concerns over the development of antibiotic resistance in bacteria, against the expense of developing new drugs and the desire for the manufacturer to make a profit.

To prevent the development of antibiotic resistance and stronger so-called “superbug” pathogens, when the medical community gets a new antimicrobial drug, it uses it only sparingly. However, since drug companies are reimbursed on a per-pill basis, this means that they could spend hundreds of millions of dollars developing a new antibiotic, and then not see much money from it. This results in few manufacturers wanting to invest their money into antibiotic development.

Gottlieb put forward the newly proposed licensing idea as a possible solution that would spur development.

“Under such a model, the acute care institutions that are most likely to prescribe these medicines would pay a fixed licensing fee for access to the drug, which would offer them the right to use a certain number of annual doses,” Gottlieb wrote. “This is similar to the way that software often gets reimbursed, where institutions pay a licensing fee for a fixed number of installations.”

While the idea was announced at the same time as a new draft guidance on how the industry should approach development of limited-use antimicrobial and antibiotic drugs, Gottlieb indicated that the FDA is still working with the Centers for Medicare and Medicaid Services (CMS) to determine how feasible the idea is, and whether it would have the intended public health benefits. Thus, the proposal is not part of the new draft guidance.

Health officials warn that much of the spread of antibiotic resistant bacteria stems from antibiotic prescribing practices that have largely remained unchanged in recent years.

More than 2 million Americans contract antibiotic resistant bacterial infections. About 23,000 will die from those infections. More vigilance, improved surveillance, and isolation methods are needed to prevent future infections and spread, according to the U.S. Centers for Disease COntrol and Prevention (CDC).