FDA unveils efforts to speed complex generic approval
SILVER SPRING, Md. — As it continues to expand on its Drug Competition Action Plan, the Food and Drug Administration has outlined new efforts to make it easier for manufacturers to bring complex generics to market. In a post on the FDA’s blog, commissioner Dr. Scott Gottlieb noted that in many instances complex drugs — which include drugs with complex active ingredients and complex drug-device combination products — do not have generic competitors for various reasons.
“The new policies we’re announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs,” Gottlieb wrote. “This focus is critical because, first and foremost, these drug products provide important therapies to patients. They are also becoming increasingly significant to the economic health of the generic drug industry. Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug maker that helps underwrite the costs of other generic applications.”
Among the efforts is a draft guidance to assist manufacturers submitting abbreviated new drug applications for complex generics in creating and submitting preliminary requirements. The draft guidance is designed to give the FDA the ability to give better advice to sponsors looking to enter the complex generics space.
“These meetings will allow for enhanced communication between generic drug applicants and FDA early in the generic drug development process, allowing for more efficient generic drug development, review, and approval pathways. We’ve found from analyzing our new drug program, that early and better meetings between FDA and sponsors can improve development timelines. We want to bring these same types of opportunities to developers of complex generics."
The agency also is issuing another draft guidance to help manufacturers determine when submission of an ANDA for peptides — compounds made up of 40 or fewer amino acids, which constitute a number of branded medicines that don’t currently have generic competition despite having lost exclusivity — would be appropriate. Gottlieb said that the draft guidance would help ensure that the risk of an immune responsive from a generic due to impurities will not differ from the reference drug.
“We’re doing all of this without sacrificing the scientific rigor of the process one bit,” Gottlieb wrote. “A central aspect of our approach, and our efforts to spur innovation and generic competition, is focused on adopting more rigorous and sophisticated science, including sophisticated quantitative methods and computational modeling, in drug development, evaluation and review.”
Gottlieb said the agency would be releasing more policies to spur complex drug competition, and that it would be doing more than releasing guidances. In the next year, he said the FDA would be looking to identify gaps in science and develop more tools aimed at better clinical endpoint testing, particularly for complex drugs that can’t be measured through typical bioequivalence methods or that don’t have an efficient or convincing bioequivalence test method. It also will hold scientific workshops around quantitative modeling approaches, among other opportunities for complex drug development, in the hope that they will speed product development and keep development costs down while improving patient access.
“Our announcements today are part of a broader effort by the administration to address the high and rising cost of drugs and in the coming months, we’ll advance other policies aimed at enabling generic competition to complex drugs,” Gottlieb said.
Diplomat acquires 8th Day Software, names founder CIO
FLINT, Mich. — Diplomat Pharmacy has made its second acquisition in two months, expanding the service capabilities of its EnvoyHealth support division and bringing on a new chief information officer in the process. The company has acquired 8th Day Software and Consulting, naming founder Dave Loschinskey CIO.
With the acquisition, EnvoyHealth can now offer its healthcare partners such services as IT outsourcing, consulting and product development.
"In an interoperable world, technology delivers comprehensive insight and sustainable value for patients and healthcare partners," said Jennifer Cretu, senior vice president of pharma services and marketing at Diplomat.
Loschinskey founded 8th Day in 2013, which has experience building technology for such services as patient engagement, reporting, hub management, payer services and more. In his new position, Loschinskey, who has more than 20 years’ experience in software development and technology, will have oversight for Diplomat’s IT product strategy and day-to-day operations, with a focus on the specialty pharmacy space.
"The health care market has shown significant demand for information technology services," Diplomat CEO and chairman Phil Hagerman said. "Dave built 8th Day along with past Accredo leaders, and their unique healthcare experience will bring new opportunities to provide better and broader services for our customers. Diplomat continues to move its analytics capabilities up the business intelligence curve from descriptive to predictive."
Before founding 8th Day, Loschinskey was with Accredo — which joined Medco and is now Express Scripts’ specialty pharmacy — as VP software development, moving on to be CIO and then VP business innovation. He also has served as senior director for computer technology company Oracle.
"Since our founding, 8th Day has built technology designed to help our customers best serve their patients," Loschinskey said. "The same patient-first mentality is woven into Diplomat's culture, making this partnership all the more exciting. I'm proud to join such an innovative company as Diplomat."
FDA approves Novo Nordisk’s Fiasp fast-acting insulin
SILVER SPRING, Md. — The Food and Drug Administration has approved a new fast-acting mealtime insulin from Novo Nordisk. The agency granted approval to Fiasp to treat adults with diabetes.
The drug is a formulation featuring the company’s NovoLog insulin aspart developed with the aim of achieving properties that more closely match the natural physiological insulin mealtime response of someone without diabetes.
“We are very pleased that Fiasp will now also be available to people with diabetes in the United States,” Novo Nordisk EVP and chief science officer Mads Krogsgaard Thomsen said. “The fast action profile of Fiasp allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”