How we fix America’s dated drug approval process

At the height of the AIDS epidemic, the AIDS community launched a powerful campaign to push the Food and Drug Administration (FDA) – the government agency that oversees testing of drug safety and efficacy-  to review and approve HIV and AIDS drugs at a much faster rate. It was clear that drugs were being developed that would help HIV and AIDS patients live longer, but these drugs were being held up in an approval process hamstrung by lack of adequate funding. That was unacceptable.

As a result of our efforts, Congress passed legislation that would augment the FDA budget with user fees -- which amounted to about one-third of the FDA’s $3.2 billion budget in FY2010.  On the whole, the system of charging fees has worked and, since the user fees for drug developers went into effect in 1992, more than 1,100 new medical treatments have come to market while approval times have dropped. In recent years, as the number and complexity of drug submissions has risen, the FDA’s performance has lagged. Furthermore, after falling impressively in the early part of the decade,  drug approval times have begun to creep up: in FY2004, the median approval time for standard drug applications was about 10 months while in FY 2005 median review times increased to 13.2 months, and in FY 2007, the median standard approval time increased to 15.1 months.  It’s clear that the FDA can do better.

Many of the delays seem to stem from new authority that the FDA acquired in 2007 to require “risk mitigation and evaluation strategies” to make sure that drug benefits outweigh their potential harms. Such strategies consist of guides distributed with medications and sometimes other efforts like “communications plans” to educate medical professionals and patients about drugs’ costs and benefits.

While it’s hard to find someone who disagrees with these efforts in principle, they add time to a process that’s already too slow. In the meantime, many patients have suffered and even died awaiting drugs that could ease their pain and save their lives.

To fix this, Congress and the FDA have to do three things.  First, the FDA needs more resources to carry out its mission.  The benefits of having new miracle medicines move more quickly to market far outweigh whatever costs they incur and are worth paying even in a tight budget climate. In any case, the FDA represents just about one tenth of one percent of the total federal budget.

Second, the FDA needs to revise the way it works.  Although the staff is competent and professional, many FDA offices don’t communicate as well as they could and new responsibilities have slowed down the whole process.

Finally, industry and the FDA need to work together to make the entire drug approval process consistent, transparent, predictable and based upon the best available science.

Twenty years ago, The FDA was unable to manage the increasing drug review workload in a timely fashion.  As a result of mounting drug applications and advocacy from patients in the 1980s and early 1990s, Congress passed legislation that resulted in a dramatic decrease in the drug review times at the FDA.  While the FDA was initially successful at reducing review times, new data indicates approval review times are trending back upwards.  Despite FDA Commissioner Hamburg’s courageous efforts, there are signs that part of the FDA’s mission – bringing innovative treatments and life-saving medicines to patients faster – may be in jeopardy. For millions of patients who await life-saving medicines, it’s time to rethink our nation’s approach before it’s too late.

Frank J. Oldham, Jr. is president and CEO of the National Association of People with AIDS.