- The Food and Drug Administration is "taking new steps" toward finalizing guidance aimed at making it simpler for generics manufacturers to bring drug-device combination treatments to market, according to Commissioner Scott Gottlieb.
- Such combos are difficult to copy because often the devices they employ are complex or protected with an array of patents and other intellectual property defenses. Speaking at the Generic Drug Science Day on Tuesday, Gottlieb acknowledged these difficulties and reaffirmed his agency's goal of optimizing the approval process for complex generics.
- "[U]nder this guidance, as long as the generic applicant is able to demonstrate with data, where appropriate, that differences in the design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met," he said.
While the FDA has always been mindful of drug pricing, it appears more comfortable weighing in on the topic since Gottlieb took over earlier this year. In October, for instance, the agency issued draft guidance about abbreviated New Drug Applications — the filings used to gain approval for copycat drugs — that detailed when pharmas should hand in those filings and how they could make the most out of their pre-submission and mid-review cycle meetings with regulators.
Through such efforts, Gottlieb appears focused on increasing competition as a way to indirectly check rising drug prices.
Yet even before Gottlieb came aboard, the FDA was working to improve the approval process for generic versions of complex drug-device combos. The agency released draft guidance on that very topic in January, outlining the expectations it has such products, including that lay-persons like patients and caregivers be able to use the new, substituted devices without training.
"The final guidance clarifies new policies related to these situations," Gottlieb said. "This includes a principle we’re setting out that allows a generic product to have certain labeling differences from the branded product — if such labeling changes stem from permitted design differences."
The guidance could shake up the drug-device space, where developers of branded products have long held an upper hand over generics makers. Franchises like GlaxoSmithKline plc's Advair (fluticasone propionate) and Mylan N.V.'s EpiPen (epinephrine), which have successfully warded off generic competition over the years, would likely face a more difficult battle if other devices were able to gain approval without being exactly the same.
Also on the line are hundreds of millions of dollars worth of revenue. GSK, for instance, relies on Advair for a large chunk of its total pharmaceutical sales. In the third quarter, however, the drug for asthma and chronic obstructive pulmonary disease brought in £743 million (about $1 billion), a 15% decrease under constant exchange rates from the same period in 2016. GSK attributed the slip to pricing pressures and continued competition from generics in Europe.