FDA chief urges ‘new era of partnership’
CAMBRIDGE — The head of the US agency that approves medicines Friday called for more regulatory flexibility and “a new era of partnership” with the biopharmaceutical industry in bringing new treatments to patients.
“We see this model emerging where we don’t just wait for an application to come to us,” Food and Drug Administration commissioner Margaret Hamburg told more than 300 drug-making executives at the annual meeting of the Massachusetts Biotechnology Council trade group. “We engage with you early and work with you throughout the development process.”
Hamburg said the partnership promised “swifter, more efficient product development and product review” after years of criticism from the industry that the drug approval process was too long and cumbersome. FDA officials last year added a “breakthrough therapy” designation to its arsenal of programs meant to accelerate the review of drugs that address pressing unmet medical needs and improve the communications between drug companies and regulators.
Together, the programs can help cut three to five years off the research and development cycle and months off approval times for new drugs, she said.
“We are working hard to find ways to decrease the time between discovery, research, and approval,” Hamburg told her audience at the Royal Sonesta Hotel. “It matters to all of you, but it especially matters to patients.”
US Senator Elizabeth Warren , Democrat of Massachusetts, who introduced Hamburg, repeated a call she made at a Greater Boston Chamber of Commerce forum last fall to double the National Institutes of Health budget, which funds scientific and biomedical research at Massachusetts teaching hospitals. Many state biotechnology companies piggyback on that research to develop therapies to treat a range of diseases and chronic conditions.
“That is absolutely critical to our future,” Warren said.
Despite the call, few think a huge NIH budget increase is forthcoming. Last month, the Obama administration asked Congress to approve $30.3 billion for the NIH in fiscal year 2015. The request marked a small increase from the $30.1 billion NIH budget allocated for the current fiscal year. But it would still be hundreds of millions less than the $30.8 billion the grant-making agency received in fiscal 2012 before across-the-board cuts known as sequestration.
Warren also said the FDA should be given the funding resources to hire more qualified scientists to work with their industry counterparts in the drug approval process.
Hamburg’s address to the MassBio gathering was her second in as many years. During last year’s appearance, about 20 people marched outside the Royal Sonesta to protest what they said was slow FDA action in getting new drugs to patients. They wore T-shirts reading “Fix the FDA” and carried signs reading “Slow FDA Costs Lives.”
This year there were no protesters. But in a private meeting between Hamburg and a small group of biotechnology executives, the topics included the role of patients in drug development and giving patients with terminal illnesses access to unproven and potentially dangerous experimental drugs without harming clinical studies designed to prove the drugs’ benefits for larger patient populations.
“The patient voice, the patient experience is very important,” Hamburg told reporters after her speech.
“We have a major program underway to meet with patients and scientists working in very specific disease areas to understand what are the big issues in those areas from the patients’ experience and how should we look at risks and benefits.”