The principal question facing President Obama's FDA will not revolve around drug safety or transparency, says Robert Goldberg, Co-founder and vice president of the Center for Medicines in the Public Interest. Obama's FDA will have to answer the question, "Who lost innovation?"
The attention now centered on drug safety will shift towards understanding the lack of innovative medicines. "Safety will become old news," Goldberg explained to attendees at the second annual Risk Management and Drug Safety summit held at the National Press Club here in Washington, D.C. last week. "What's new is deadly delay." As FDA delays move to the forefront, regulators and drugmakers will be forced to address technological and regulatory issues that have hampered the development and approval of new drugs to treat unmet needs.
What to expect
Among the key issues the FDA faces are regulatory standards for generics, personalized medicine and regulatory science.
The critical path will become a permanent part of the FDA and the agency will address the questions surrounding how and what standards to apply to innovative drugs and generic therapies. Currently, many principles applied to innovative products are not applied to generics, explained Goldberg.
But the need for drug cost savings will not top drug safety needs, Goldberg said assuredly. While there is pressure to find savings from generics, Congress understands that the science of biologics requires the FDA to develop standards and that the regulatory path for generics should not be legislated.
As for personalized medicine, it will continue to facilitate the regulatory process. Drug developers can expect regulators to ask for experimental studies. Goldberg believes such studies are of little value, but the pressure is growing for regulators to approve drugs that work in pivotal trials initially rather than forcing companies to produce additional genome based data.
With Margaret Hamburg (photo) and Joshua Sharfstein (photo) at the helm, Goldberg expects major changes in the way regulatory science is managed. Of Commissioner Hamburg, he exalts, "she gets the big picture." She and Deputy Commissioner Sharfstein "see the clear relationship between the advances in medical science and the public health."
"Dr. Hamburg will make regulatory science a hallmark and signature issue of her commissionership." It will be her focus on regulatory science, not her efforts to ensure transparency, that will define her legacy as FDA Commissioner, says Goldberg.
The Hidden Problem
These are certainly important issues, but as we consider reforming our healthcare system, there is one problem that may just trump all of them. As Sir Alasdair Breckenridge, Chairman of the U.K.'s medicines and healthcare products regulatory agency pointed out at the summit, patient adherence and compliance is a major public health problem hidden in plain site.
Lack of compliance to drug treatment programs is at the root of many drug safety issues. As we've reported, poor compliance results in additional healthcare costs in the hundreds of millions. Pharma has already caught on: offering drugs at major discounts to ensure that cash-strapped patients will be able to afford to continue taking their medication as directed. But efforts to increase patient compliance will need to be multi-faceted and will require novel tools, says Goldberg.