U.S. senators re-introduce a bill to speed approval of antibiotics
In the latest bid to combat antibiotic resistance, two U.S. senators have re-introduced legislation to create a so-called regulatory pathway to hasten approval of new treatments.
Known as the Promise for Antibiotics and Therapeutics for Health Act, the bill would accelerate approval for a serious or life-threatening condition that addresses an unmet medical need. The PATH act would also require labeling to include a special FDA designation indicating intended use in limited, high-risk populations.
“We need new drugs to fight antibiotic-resistant bacteria that are posing serious and unique challenges to health care professionals,” says U.S. Sen. Michael Bennett (D-Co.), who co-sponsored the bill with U.S. Sen. Orrin Hatch (R-Utah), in a statement. They had introduced the same bill last month, but re-introduced the legislation now that a different congress is in session.
The legislation arrives four months after the Obama administration released a game plan for dealing with the growing problem of antibiotic resistance, which has been blamed for at least 2 million illnesses and 23,000 deaths annually in the U.S. alone. The strategy calls for specific steps to develop new antibiotics by 2020 and measures to prevent the spread of drug-resistant bacteria.
These steps include supporting basic research, generating opportunities for so-called public-private partnerships, creating a biopharmaceutical incubator and forming international collaborations. And antibiotics being developed directly or sponsored by different federal government agencies are targeted for further testing or regulatory approval over the next few years.
The White House plan, however, garnered some criticism from consumer advocates, who complained the effort does not go far enough and, instead, takes what some called a wait-and-see approach to tackling the extent to which large-scale farming contributes to antibiotic resistance in humans. This is seen by various consumer groups as the chief culprit behind the problem.
The senators did not specifically address the use of antibiotics in food-producing livestock, but other senators have been pushing the FDA to take steps to more closely track and curtail usage. In any event, the bill was applauded by several groups that are concerned antibiotic resistance will only worsen without incentives to develop new medicines sooner than later.
“Our analysis of the antibiotic pipeline shows about 38 new drugs in some stage of clinical testing,” says Allan Coukell, senior director for health programs at The Pew Charitable Trusts. “But few were for the most serious bacterial threats and we need more policy tools like the PATH Act if we are going to spur meaningful drug innovation.”
Source: Pharmalot
