Expedited FDA Approval Process Will Not Lower Drug Prices
Federal law allows the FDA to shorten both the clinical trial and approval processes for a large number of prescription drugs.
Recent analysis by the Center for American Progress (CAP) outlines why speeding up the FDA drug approval process will have no effect on lowering drugs costs and will only bring harm to patients.
Currently, more than 70% of Americans believe that drugs prices are “unreasonable” and that “drug companies put profits before people.”
The analysis stated the FDA currently has enough flexibility that allows the drug approval process to be accelerated safely and effectively. In fact, the FDA approves a majority of new drugs far more quickly than any other nation, the CAP report noted.
“There is enough flexibility already in the FDA approval process to bring lifesaving drugs to the market in a timely manner,” said author and Director of Healthy Policy at CAP, Maura Calsyn. “The current process strikes a critical balance between speed and diligence.”
In 2015, the FDA approved 64% of new innovative drugs before they were approved in other countries around the globe. Additionally in 2015, 89% of novel drug applications were approved, while 100% were approved in 2014.
After an analysis conducted by Forbes on FDA approval from BioMedTracker, it was concluded that “the FDA is basically approving everything.”
Furthermore, in order to speed up the process of getting new drugs to the market, the federal law already allows the FDA to shorten both the clinical trial and approval processes for a large number of drugs.
The expedited programs were created by policymakers to speed up the development and approval of new drugs that help patients with serious or life-threatening disease. The 4 principal programs that vary in criteria include: fast track designation, breakthrough therapy designation, accelerated approval, and priority review.
“(These pathways) help ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks,” the FDA said. “These pathways are of particular importance when there are few—or no—treatment options. (They are most helpful) in settings in which the disease course is long and an extended period of time would be required to measure the intended clinical benefits of a drug.”
Under the accelerated approval and fast track designation programs, 32% of new molecular products that include biologics were approved between 2000 and 2013.
However, because these expedited drugs are approved using less data and information, they can carry dangerous side effects or be far less effective than originally thought further down the line.
Many experts state that if the FDA’s approval standards were changed, it could bring harm to patients. Despite this, many lawmakers support the 21st Century Cures Act, which includes numerous policies that would allow the FDA to grant approval with far less scientifically rigorous evidence. This allows more drugs to enter the market and could potentially put patients at risk.
Furthermore, there is no supporting evidence that shows that changing these standards would speed up the approval process or lower drug prices.
In 1992, researchers discovered that when policymakers adopted the priority review and accelerated approval programs, the amount of approved prescription drugs that received black-box warnings or were withdrawn from the market due to safety increased by 25%, the study found.
There has been continuous arguments over drug prices increasing at devastating speeds, with manufacturers claiming that the revenue from expensive therapies are subsequently used for the research and development of new drugs. They have even attempted to shift the blame for high drug costs to the FDA, despite the drug companies being responsible for the pricing of these drugs, the CAP noted.
The pharmaceutical industry stated that the actual regulatory review time is only a part of the process, with the pre-approval process of drug development and testing taking too long and costing too much. These approval requirements were put in place to ensure new drugs that become available on the market are safe and effective.
The authors of the study stress that undermining the FDA or cutting corners will have no effect on lowering drug costs. In fact, drug prices have continued to rise, despite the increase in approvals through expedited pathways.
When Gleevec was first approved, it was priced at $4500 (in 2014 dollars) for a monthly supply. In 2014, the price had increased to $8500, the study noted.
In some cases, however, accelerating the approval of competitor drugs can help reduce prices. Branded competition can give payers leverage in order to negotiate sizable discounts or to limit the price increase by tethering drug coverage to price. But these situations are based off of pricing strategies, similarity of competing drugs, and other readily available treatment options.
Although there are examples of new drugs inciting price competition, they were met with examples of pharmaceutical companies taking advantage of the shift in market dynamic so they can price their competitor drugs higher than the original drugs.
The CAP released a set of integrated reforms in September that challenged public officials and lawmakers to make lowering drug costs a priority.
The report lays out new policy recommendations to help achieve this with transparency to the pharmaceutical industry, encouraging innovation by rewarding drugs that have significant benefit to patients, with several more options that do not require new federal legislation.