Pharmaceutical industry leaders indicate the federal government's review process for the approval of new drugs and medical devices has improved in recent years, according to new report. But questions remain regarding whether changes to the regulatory process are needed to ensure quicker release of new products.
The Food and Drug Administration's review time for new drugs and biologics has gone down in recent years from an average 13 months in 2008 to 10 months in 2010, 2011 and 2012, according to a survey of 100 pharmaceutical and life sciences company senior executives released this week (PDF).
The agency's time to approve pre-market approval applications for new medical device applications also went down, from 14 months in 2009 to roughly seven months by 2012, according to the findings of the survey conducted by consulting firm PricewaterhouseCooper.
Respondents, however, did see problems with the average time the FDA took to approve products designated under its Priority Review process, which was designed to improve drug review time for drugs deemed to have “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” as explained on the agency's website.
Drugs that undergo Priority Review are supposed to receive action on their application within six months, according to the FDA, compared with the 10-month review time given to products reviewed under the standard evaluation process.
While survey respondents reported improvements made in Priority Review times for drug applications, falling from an average of 11 months in 2008 to six months by 2012, device review times fluctuated during the same period.
Device review times under the FDA's accelerated process increased from six months in 2008 to 16 a year later, only to fall down to an average of eight months by 2012.
The report also found improvements in the number of standard and priority review applications that received FDA approval on a first attempt. Only 38% of drug and biologics applications under standard review got first-cycle approval in 2008, a rate that climbed to 58% by 2012. The first-cycle approval rate among priority reviewed drug applications also went from 56% in 2008 to as high as 91% in 2011, but fell to 81% by 2012.
Overall, industry leaders' view of their relationship with the FDA has improved in recent years. More than three-quarters of survey respondents reported having better and more frequent communications with the agency, with 70% saying the FDA has offered more applicable guidance over the past two years.
Industry leaders' feelings about whether the FDA should include cost-effectiveness within their evaluation of products has shifted, according to the survey, with 43% of respondents saying they were open to having economic value of their products included as a consideration compared to just 14% in 2010.
“Manufacturers will need to demonstrate value over existing therapies as both purchasers and consumers look for products that meet their medical and financial needs,” the report stated.
The report also surveyed 1,000 consumers, who had a more negative view of the FDA review process. Only about 39% said they believed the FDA takes into consideration the public's views during the review process.
Such sentiment could help explain an increase in the number of states that have passed so-called, “right-to-try” laws over the past year. Five states passed laws in 2014 that would allow dying patients to get drugs and medical devices not yet approved by the Food and Drug Administration.
Similar types of legislation are currently being considered in 24 other states, according to the Phoenix-based, Goldwater Institute, a not-for-profit conservative research organization that has lobbied state governments across the country to pass right-to-try laws.
Critics say the laws amount to nothing more than political statements against federal regulation since such laws do not require drug and devicemakers to make their products available for dying patients and therefore do nothing to increase access.
Follow Steven Ross Johnson on Twitter: @MHsjohnson
