Relationship between industry, FDA is strained, PwC report finds
NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans’ approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.
The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.
“Consumers want safer, more effective drugs and devices, and access to the latest medical innovation,” stated Michael Mentesana, PwC’s U.S. Pharmaceutical and Life Sciences Research and Development Advisory Services leader. “Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost health care that demonstrates enhanced economic and clinical value,” he said. “Hope lies in accelerating scientific and technological advancement as we learn more about genetic differences and individual responses to treatments. But the promise of faster product development has yet to be realized, and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations.”
The study found that life sciences companies feel communication with the FDA has improved steadily since passage of the FDA Modernization Act of 1997, but new expectations are fueling frustration with the regulatory review process.
According to the report, the industry feels that the FDA is not keeping up with rapidly advancing technology — only 8% of drug and device makers think the FDA is doing enough to advance personalized medicine. And more than half (56%) of respondents who are familiar with the FDA’s Critical Path Initiative to bring innovative, high-priority therapies to market quickly think that the FDA currently lacks the capability to implement that initiative.
Only 38% of life sciences companies in the study said they feel that the overall working relationship with the FDA has improved over the past two years, though 80% reported that the FDA is providing better guidance about its expectations.
More than half of companies (64%) said that meeting with the FDA before submitting review materials improved the quality of their applications, and 87% said it expedited their applications. But the industry has not always taken advantage of the meetings and only about half (53%) said the FDA consistently encouraged these meetings.
Six-in-10 companies expressed frustration that the FDA had changed its position during a review, and 4-in-10 feel that some products were denied because of the FDA’s inadequate review resources.
The latest in a series of PwC reports over the past 15 years on the working relationship between the life sciences industry and the FDA, the report provides feedback from 50 life sciences companies, including the makers of biologics, drugs, medical devices and diagnostics.
The PwC report also suggested that the lay public has several misconceptions around drug development.
Walgreens’ 90-Day at Retail program garners big savings for Navitus’ PBM clients
DEERFIELD, Ill. — An alliance between a drug store chain and a national pharmacy benefit manager resulted in more than $3 million in savings over a seven-month period for the PBM clients.
Walgreens said by offering its 90-Day at Retail program to Navitus Health Solutions, which gives all covered members of Navitus PBM clients the 90-day supply option for certain medications from local community pharmacies, resulted in $3.3 million in savings in seven months. What’s more, the implementation of the program also has led to an additional six to 11 percentage point improvement in the generic dispensing rate for 90-Day at Retail prescriptions (up to 77.3%) when compared with those filled via mail. This increase is generally driven by the benefit of the face-to-face interaction with the pharmacist where the patient is being advised, if appropriate, that there is a cheaper generic alternative, Walgreens noted.
Walgreens also reported that the penetration rate of its 90-Day at Retail program increased more than 67%. More than 1 million people covered through the Navitus network currently have access to the 90-Day at Retail program.
The program was initiated in February and was measured through September, Walgreens said.
“Results from Navitus’ clients demonstrate what we already know; namely that when they are given the option and made aware of it, employers and consumers see significant value in 90-Day at Retail, and the program can drive lower costs,”said Colin Watts, Walgreens chief innovation officer. “This is key for payers, such as Navitus, who also need to measure and improve outcomes for their members, and is part of the reason our unique set of healthcare solutions is increasingly resonating with payers and employers.”
Ranbaxy launches generic Aricept
GURGAON, India, and PRINCETON, N.J. — Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer’s drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.
Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Labs, will manufacture and market donepezil hydrochloride tablets, a generic version of Aricept, in the 5-mg and 10-mg strength in the United States.
"We are pleased to announce the launch of donepezil, which expands Ranbaxy’s portfolio of affordable generic pharmaceuticals. Ranbaxy’s generic formulation of Aricept will benefit the U.S. healthcare system by providing a more affordable treatment option to patients, which will have a positive impact on escalating U.S. healthcare costs," said Bill Winter, VP trade sales at RPI.