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How Many Months Does It Take the FDA to Approve a Drug for Marketing?

How Many Months Does It Take the FDA to Approve a Drug for Marketing? | Pharma Industry Regulation |

In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in need.” He went on to say that if “we slash the restraints” then we can ostensibly speed the arrival of new medicines (read “Trump Disses FDA as ‘Slow and Burdensome’”;

But is it accurate to characterize the FDA’s process as slow and burdensome?  Are new treatments in fact being kept from reaching people in need?  Are people with rare diseases having their hopes for treatment quashed by an overbearing bureaucracy?

These questions are actually not new. In fact, they have been around for quite some time and most certainly came to a head when in the early years the HIV/AIDS epidemic was exacting a heavy toll and there were no treatments. How to speed approvals has long been a question that has always interested policy makers. And while the objective of doing so is everyone’s goal, experience has demonstrated that achieving the goal is more likely the result of a process than an event.

According to testimony submitted by the General Accounting Office before the Senate Committee on Labor and Human Resources in 1996 on FDA Review and Approval Times, in 1987 it took an average of 33 months for New Drug Applications (NDAs) submitted to the agency to be approved. This was during the early and very savage years of the AIDS epidemic when thousands upon thousands of people were dying without any meaningful treatment for their HIV infection. According to the same testimony, by 1992 – just 5 years later – the number of months to approve a new drug had dropped to 19 months.

More improvement was forthcoming. With the advent of the Prescription Drug User Fee Act (PDUFA) in 1992, the agency acquired new revenue that allowed for an expanded capacity to review NDAs with the consequence that approval times were reduced even further. To make a long story short, today PDUFA brought the consideration time for a new drug just 10 months in most cases, and even faster in special cases.

Pharma Guy's insight:

Of course, the real issue is how long it takes drug companies to come up with the evidence in order to submit an NDA (New Drug Application) to the FDA. Pharma has won the battle to get FDA turnaround times down to the bare minimum. It now has to turn to allowing drugs to be approved with less evidence. That's really what this is all about. FDA is just a convenient scapegoat, IMHO.

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