Navigation Links
Lilly CEO Says Appropriate Assessment of Both Benefits and Risks Critical in Regulatory Process
Date:11/2/2011

WASHINGTON, Nov. 2, 2011 /PRNewswire/ -- To sustain medical innovation, the FDA must accelerate the adoption of a Benefit-Risk framework to inform decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company (NYSE: LLY).  

In an address at the FDA News Fourth Annual Risk Management and Drug Safety Summit, Lechleiter called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

"The stakes are high," Lechleiter said. "The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress."

The upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V provides an important platform to address these issues. PDUFA, first enacted in 1992, sets the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lechleiter stressed the importance of a non-partisan course for reauthorization. "As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics," Lechleiter said. "As Congress considers reauthorization next year, we hope to see a 'clean' bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties."


Even after PDUFA V, Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.  He outlined five characteristics of a "state of the art" regulatory approval system:

  • Timely – "There are far too many conditions for which therapy is inadequate or nonexistent.  We need a system that is not only effective, but efficient as well."
  • Predictable – "The system must be predictable in its judgments, its decisions, and the criteria on which those decisions were based – whether scientific, ethical, legal, etc."
  • Consistent – "The system must be consistent across review divisions using standardization and repeatable processes – so that an innovator clearly understands the regulatory requirements and so that institutional learning can be harnessed to replace time-consuming one-off learning by review groups and division."
  • Transparent – "The system needs to be transparent in its judgments and criteria so [stakeholders] understand the rationale for its decisions."
  • Scientifically rigorous – "This requires scientific expertise within the agency – or access to the expertise – that understands, engages in, and influences the constantly evolving external scientific environment and ensures that standards are up-to-date."

Lechleiter also discussed ways to strengthen a medicine's benefit and lower its risk, including calling for greater emphasis on improved outcomes for individual patients, through the development of tailored therapeutics.

"From the point of view of patients and their doctors, a tailored therapy will provide a better benefit/risk trade-off, because they can have a higher degree of confidence that it will work effectively and with minimal harmful side-effects relative to the benefit obtained," said Lechleiter. "From a value-for-money standpoint, tailored medicines should also reduce the heavy costs associated with non-responders. In other words, payers will get what they are paying for."

Lechleiter concluded his speech by calling for a change in the mindset and culture: from one focused disproportionately on risk to one that seeks to balance risk and benefit.

"We look forward to a partnership (between industry and FDA) that is uniquely effective in finding the appropriate balance and advancing the interest of public health."

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

C-LLY    

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO)


'/>"/>
SOURCE Eli Lilly and Company
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Lilly Foundation Commits US $30 Million to The Lilly MDR-TB Partnership
2. Lilly Provides Update on 2011 Financial Guidance Due to Xigris Withdrawal
3. Prasco® Selected as Eli Lilly and Companys Authorized Generics Partner
4. Lilly Reports Third-Quarter 2011 Results
5. Lilly Declares Fourth-Quarter 2011 Dividend
6. Lilly Announces Changes in Senior Management
7. Lilly Confirms Date and Conference Call for Third-Quarter 2011 Financial Results Announcement
8. Lilly Improves Its Environmental Footprint in Business Operations and Helps Beautify Communities
9. Eli Lilly and Company Bringing Diabetes Education Program to the Annual Legislative Conference
10. Lilly Celebrates 17th Consecutive Year as One of Working Mother 100 Best Companies
11. Lilly Health Channel Debuts on YouTube
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/4/2017)... Korea , Oct. 4, 2017  South Korean-based ... next-generation CPR training aide "cprCUBE" on Kickstarter. The device ... compression during cardiac arrests with better efficiency compared to ... also offers real-time feedback on efficacy of the compression ... crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... , Oct. 2, 2017  Eli Lilly and ... financial results for the third quarter of 2017 on ... conference call on that day with the investment community ... The conference call will begin at 9 ... can access a live webcast of the conference call ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Many families ... However, many long-term care insurance companies have a waiver for care if the client ... elimination period, when the family pays for care, is often waived, so the benefits ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for ... for action towards gender equality at their inaugural Summit in New York City in ... reached a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a ... has been awarded a contract by the Center for Medicare and Medicaid Services ... accelerate the enterprise use of Agile methodologies in a consistent and high value ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
Breaking Medicine News(10 mins):