By Guy Anthony
Congressman Frank Pallone, Jr. recently introduced a bill that could delay patients’ access to lifesaving treatments — and even take FDA-approved medicines away from patients who are already using them. As a Black man living with HIV and a lifelong advocate for patients, I fear this legislation will have disastrous consequences for millions of Americans, especially the most vulnerable among us.
The bill essentially neuters the FDA’s “accelerated approval” pathway, which regulators established at the height of the HIV/AIDs epidemic. In the late 1980s and early 1990s, thousands of Americans were dying from this disease each year. Patient groups pleaded with the FDA to expedite the approval of promising treatments.
Regulators listened — and in 1992 created a pathway to expeditiously assess the efficacy of treatments for serious and life-threatening conditions like HIV. Rather than measuring “clinical benefit” — an increase in long-term survival rates, for instance — the FDA began assessing HIV medications based on “surrogate endpoints” — markers that are likely to predict clinical benefit, such as higher t-cell counts that enable the immune system to suppress the virus.
The pathway gave patients faster access to medicines that saved their lives. Had the drugs gone through the traditional approval process, it would have taken additional years to definitively prove they extended life expectancies.
Drugmakers still have to conduct confirmatory trials to ensure the medications ultimately provide the anticipated clinical benefit. Only after these trials are complete can drugs receive traditional FDA approval.
The accelerated approval pathway has extended and saved thousands of HIV patients’ lives. Between 1992 and 2010, roughly 40% of the drugs approved through the accelerated pathway treated HIV. The FDA later granted all of them traditional approval.
I can’t help but think how my story could have been different, had I not had immediate access to some of these treatment options when I was diagnosed with HIV. I wasn’t even 20 years old. But thanks to cutting-edge drugs, I’ve lived a fairly normal life for the past 17 years.
All told, more than 260 drugs treating conditions ranging from HIV to cancer to rare diseases have gotten to patients quicker thanks to the accelerated approval pathway.
They also offer greater health gains than medications approved through the traditional FDA pathway, according to research in Health Affairs.
Despite the success of accelerated approval, Congressman Pallone have taken aim at the pathway. His bill could pull medicines off the market if post-accelerated-approval studies haven’t been completed within five years. It could subject drugmakers to criminal penalties if they don’t conduct confirmatory trials with “due diligence” — in other words, on a vaguely defined timetable set by bureaucrats. And it could deter patients from weighing in on a medication before the FDA withdraws its approval.
These draconian measures could discourage drugmakers from applying for accelerated approval. After all, why would a manufacturer make efforts to recruit and retain patients in complex, expensive clinical trials just for the FDA to pull its drug from the market?
Minority patients will suffer disproportionately from such decisions. That’s because Americans of color bear the outsized burden of the life-threatening illnesses typically targeted by drugs given accelerated approval.
For these Americans and countless others, drugs given accelerated approval often mean the difference between life and death. Preserving this critical pathway will help ensure future patients have a chance at life — just as I had.
Guy Anthony is the president and CEO of Black, Gifted & Whole. This piece originally ran in the New Jersey Star-Ledger.
