Merck’s president steps in as new CEO
WHITEHOUSE STATION, N.J. — The president of drug maker Merck now will fill an additional position at the company: CEO.
Merck’s board of directors elected president and board member Kenneth Frazier as the company’s next leader, effective Jan. 1. Frazier will succeed Richard Clark, who has served as Merck’s CEO since 2005. Clark will continue as chairman of the board, the drug maker said.
Frazier’s career at Merck spans 18 years. Since becoming president, he has focused on improving the effectiveness of the company’s three largest divisions –– pharmaceutical and vaccine sales and marketing, research and development, manufacturing and supply –– and their post-merger integration, the drug maker said. Merck merged with Schering-Plough in a $41.1 billion deal in 2009.
PwC survey sheds light on public confidence, misconceptions about the FDA
NEW YORK — The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.
Approximately one-half of respondents reported they think the FDA does a good job, but more than one-third (36%) of U.S. consumers said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.
The lay public also has no appreciation for the time and costs invested in bringing a new drug to market, according to the survey. Slightly more than half (54%) of respondents think it takes only five years or less to develop a new drug or medical device, when it in fact can take up to 12 years in research and development and costs well in excess of $1 billion.
As many as 72% of respondents have confidence that the FDA monitors product safety after products are approved and are being sold to the public, though 28% are not confident.
And while the majority of U.S. consumers (93%) have confidence in the safety and effectiveness of drugs and medical devices approved for use in the United States, and two-thirds agree that the U.S. has the highest standards in the world for drug safety and effectiveness, more than half (56%) would be willing to use drugs and devices not approved by the FDA but approved elsewhere.
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.