Congress Writing New Bill To Speed Drug Approvals

Congress Writing New Bill To Speed Drug Approvals

March 28th, 2012 // 12:45 pm @ jmpickett

Source: Pharmalot

Yet another effort has been devised by some members of Congress to jumpstart the FDA approval process. The latest initiative is a bi-partisan bill that is called the Advancing Breakthrough Therapies for Patients Act, which would require the agency to hasten the development and review of breakthrough drugs.

What is a breakthrough drug? A drug intended for a serious or life-threatening disease or condition where preliminary clinical evidence indicates they may demonstrate substantial improvement over existing therapies, according to the senators who introduced the bill – Michael Bennet, a Colorado Democrat; Orrin Hatch, the Utah Republican; and Richard Burr, a North Carolina Republican.

How would it work? If a drugmaker or a biotech believes its med would qualify, the FDA could be asked to designate the med as a breakthrough. From the agency would meet with the sponsor through the development process, provide advice as development progresses, minimize the number of patients in clinical trials and shorten the duration of the trials, among other things (here is the bill).

“This common sense legislation ensures that patients across the country can receive breakthrough treatments faster and more efficiently than ever before,” Hatch says in a statement. “Time and again we’ve seen regulators in Washington fail to keep up with the industries they are tasked to oversee. This bipartisan bill ensures that when it comes to treating patients suffering with cancer or other devastating illnesses, science and patient care will not be slowed down by government red tape.”

Barbs aside, the legislation states that, once a sponsor requests the designation, the FDA would have no more than 60 days to determine if the drug meets the criteria. However, the bill would not preclude a drugmaker or biotech with a breakthrough med from also seeking fast-track designation, accelerated approval and a priority review.

The move is only the latest attempt to accelerate approvals. In recent months, the FDA has been under increasing attack by various drugmakers and biotechs, pundits, venture capitalists and patient groups for not speeding applications. This new bill, for instance, has backing from Friends of Cancer Research, a think tank and advocacy group, and the National Venture Capital Association.

The ebb and flow of venture capital investment, in particular, has been cited as a reason for overhauling the FDA process. Last year, the NVCA released a survey showing that US VC firms have been decreasing their investment in biopharma and device makers during the previous three years and planned to lower their commitments still more (here is the survey).

Earlier this month, a bill called the Faster Access to Specialized Treatments Act, or FAST, was introduced and discussed at a hearing held by the House Energy & Commerce Committee’s Subcommittee on Health. The idea is modeled on the effort that allowed speedier treatments for HIV and AIDS that relied on surrogate endpoints to measure effectiveness (here is the bill).

The Senate version of that bill, called the Transforming the Regulatory Environment to Accelerate Access to Treatments, or TREAT, was introduced last month and would require the FDA to hire a chief innovation officer to identify “promising new scientific and regulatory approaches to ensure the rapid development, testing, and review of new drugs and devices” (here is that bill).

Also last month, former FDA commish Andy von Eschenbach proposed the FDA should approve drugs based on safety and “leave efficacy testing for post-market studies.” In a widely debated op-ed in The Wall Street Journal, he suggested creating pilot programs in which patients would be entered in registries, and the FDA and drugmakers would later determine whether a medicine is effective (see here).

Of course, there is a regular clamor for the FDA to move faster, but the possibility that the language contained in one or more of these bills could become reality, if only because the Prescription Drug User Fee Act expires at the end of September. Since PDUFA helps bankroll the FDA with needed user fees, some ideas being proposed may find their way into the legislation that reauthorizes PDUFA.