The Antibiotic Development to Advance Patient Treatment (ADAPT) Act () was introduced in the U.S. Congress on December 12, 2013 by Representative Phil Gingrey of Georgia and fifty-two cosponsors. Responding to the lack of financial incentives for drug manufacturers to innovate new antibiotics and antifungals and the regulatory barriers to their doing so, it proposed an expedited pathway for testing drugs intended for diseases for which no cure yet existed. After it died in committee, a similar version of the Act was re-introduced by Representative John Shimkus of Illinois and his cosponsor Representative Gene Green of Texas. Though this Act likewise failed to make it out of committee, several of its provisions were codified in the 21st Century Cures Act, which was signed into law on December 13, 2016. These include the expedited testing pathway for new antibiotics and a similar provision for antimicrobial susceptibility tests.
Background
Antibiotic resistance and the barriers to new treatments
The cost of antibiotic resistance, in dollars and in lives, motivated the Act’s sponsors and the community stakeholders that supported its passage. In September 2014, the Subcommittee on Health of the House Committee on Energy and Commerce held a hearing at which officials from the Food and Drug Administration (FDA), Pew Charitable Trusts, and other organizations testified in favor of the ADAPT and 21st Century Cures Acts. Opening the hearing, Subcommittee Chairman Joseph R. Pitts (R-PA) quoted then-Prime Minister David Cameron’s recent admonition that failure to “confront the threat of antibiotic resistance” could “cast [humanity] back into the dark ages.” Speaking at this same hearing, Representative Phil Gingrey (R-GA) (the 2013 Act’s principal sponsor) referenced Centers for Disease Control (CDC) statistics, which placed the number of Americans who die from drug-resistant infections each year at around 23,000. Representative Gingrey asserted that the financial losses from such infections amount to $55 billion annually. Representative John Shimkus (R-IL) would later note these same figures in a House debate over the Acts in July 2015.
Equally worrisome to the ADAPT Act’s proponents were the economic and regulatory impediments to developing new treatments for drug-resistant illnesses. Citing the FDA, Representative Gingrey lamented during the 2014 hearing that “new antibiotic approval ha[d] decreased by 70 percent since the mid 1980s.” Representative Michael C. Burgess (R-TX) likewise took issue with the “lack of a pipeline of new drugs” to respond to the threat of super bugs. Several blamed inadequate market incentives for this paucity of remedies. As Dr. Barbara E. Murray, then-President of the Infectious Diseases Society of America, observed, “Antibiotics are typically priced low [and] used for a short duration.” Pharmaceutical companies can reap greater returns in other areas of research; hence, the development of new antibiotics flounders.
Compounding the scant financial motives for drug development, creators of new treatments were made to contend with "serious regulatory barriers". Dr. Murray observed that the small number of patients infected by novel diseases made it difficult for manufacturers to find enough test subjects in order to comply with federal agencies’ n-count requirements. The unavailability of diagnostic tests for these new infectious agents also demanded a large investment to find eligible study participants, while generating little information about drug effectiveness. Stagnant innovation becomes self-perpetuating. The more antibiotics to which a pathogen becomes resistant, the fewer controls there are against which to measure an experimental treatment.