US Legislators Sanction Drug Approval Speed-up
A bill designed to significantly streamline and hasten the drug approval process in the US has been approved by a wide margin in the House of Representatives.
The nonpartisan 21st Century Cures Act is aimed at “modernizing and personalizing health care while encouraging greater innovation, supporting research and streamlining the system to deliver better, faster cures to more patients.” The bill included an Accelerated Approval Development Plan, a Streamlined Data Review Program and a section called Reducing Administrative Burdens of Researchers.
As part of the package, the National Institutes of Health (NIH) would receive nearly $9 billion in additional funding while the FDA would get an additional $550 million. The higher funding would be paid for mostly by selling $7 billion worth of oil from the Strategic Petroleum Reserve, the government's emergency oil stockpile. Another $2.5 billion would come from trimming federal Medicaid reimbursements to states.
Under the plans, biomarkers and other “surrogate endpoints” would be leveraged to help speed approval of new drugs, thus shortening the development period. Preclinical testing, along with small trials in humans, would also play a role.
Supporters of the House draft – which still has to pass the Senate – said that with advances like genetic mapping and biologic medicines produced in living cells, regulators’ assessment of the safety of new treatments should be streamlined so that drugs could be in the market sooner.
Calling the bill “an assault on patient safety and science,” critics contended that the FDA already has an efficient approval process. Consumer advocates said the bill would trade increased federal research for “perks to the pharmaceutical and medical device industries.”
According to the web portal Drugs.com, it takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the US Food and Drug Administration (FDA) to begin testing the drug in humans.
