Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013; Public Conference

Action

Notice Of Public Conference.

Summary

The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled “Seventh Annual DIA/FDA Statistics Forum—2013.” The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical investigators who are involved in the development of new drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's “Critical Path” initiative—emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.

 

The public conference will be held on April 28, 2013, to May 1, 2013, from 8:30 a.m. to 5 p.m.

 

The public conference will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852, 1-301-822-9200.

 

For further information,  DIA/FDA Statistics Forum 2013: PDUFA V Statistical Topics and Emerging New Issues.

 

FDA and You - DIA has you covered this fall (FDASIA, UFA and PDUFA)

The Food and Drug Administration Safety and Innovation Act (FDASIA) is Law. Now What? Join DIA, Food and Drug Administration (FDA), and The Food and Drug Law Institute (FDLI) as they convene the foremost experts in separate meetings to explain the nuances and forecast the implications of the User Fee Acts—PDUFA V, MDUFA III, GDUFA and BsUFA. DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA September 12-13 | Washington, DC Co-sponsored by In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was enacted as part of the Affordable Care Act. This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as perspectives of other regulators. In collaboration with Keynote Speaker: Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) View Program Details | Enroll Today Unwrapping FDA's 2012 UFA Package: What's Inside the Statute, What's Next? September 20 | Washington, DC Co-sponsored by The content of the UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. This one-day conference will provide a first look at the final packages enacted for PDUFA V, MDUFA III, GDUFA and BsUFA. FDA will discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017. Keynote Speakers: Jeanne Ireland Assistant Commissioner for Legislation Food and Drug Administration (FDA) Jeffrey E. Shuren, MD, JD Director, Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) View Program Details | Enroll Today DIA/FDA Industry PDUFA V Conference October 18-19 | Arlington, VA Co-sponsored by This two-day conference sets the stage for professionals in the FDA, Industry, patient, consumer, and health care groups to give new perspectives to current plans and potential impact on all stakeholders on the Prescription Drug User Fee Act (PDUFA). When PDUFA was enacted in 1992, it created amazing forward thinking in public health. Patients now have quicker access to over 1,500 new biologics and drugs, focusing on cancer treatments, infectious diseases, neurological and psychiatric disorders, and cardiovascular diseases all the while maintaining FDA’s meticulous safety and drug efficacy standards. With the recent authorization of PDUFA V, this conference will explore the next steps. View Program Details | Enroll Today

Bill includes reauthorization of PDUFA, which adds fees for generic and biosimilar developers.

from Genetic Engineering & Biotechnology News

Insight & Intelligence™ : May 23, 2012

FDA Reform Legislation Emerges as Exception to Washington Gridlock

The fifth five-year authorization of the Prescription Drug User Fee Act (PDUFA V) is shaping up as a welcome exception to the rule that in a presidential election year, Congress cannot get much of anything done until after the votes are counted in November. Well before Election Day, the Senate and House of Representatives are expected to hammer out and pass a single FDA reform bill that includes PDUFA V.

“We need to enact this user fee bill by the end of June. We are on track to accomplish this goal,” Rep. Fred Upton (R-MI), chairman of the House Energy and Commerce (E&C) Committee, said. He has called for sending a bill to President Barack Obama before July 4. The Senate moved its bill onto its calendar for floor action; the House is expected to do likewise.

The Senate and House have produced two very similar versions in recent weeks. “I would say it’s pretty surprising how significantly they lined up,” Nancy Bradish Myers, president/founder of Catalyst Healthcare Consulting, told GEN. “The politicians realized that each one of these user fee agreements had good agreement between the agency and industry. They realized that with an election year, if they wanted to go home and claim to have done something significant on the healthcare front that actually helps people get the medicines they need, that a bipartisan agreement needed to be done carefully and quickly.”

for complete article, please visit http://www.genengnews.com/keywordsandtools/print/3/27255/

Lawmakers seek faster approval process for shortage drugs, from AMEDnews.com

A House subcommittee adds legislative language on shortages to the user-fee reauthorization bill.

By Charles Fiegl, amednews staff. Posted April 30, 2012.

An expedited review track as well as studies on regulations and manufacturing are being considered as possible solutions to national shortages of certain drugs.

The House Energy and Commerce health subcommittee held an April 18 hearing on draft language addressing drugs in short supply. Lawmakers are seeking to add the provisions to the reauthorization of the Prescription Drug User Fee Act. The act, which expires this year, sets fees for Food and Drug Administration reviews of drug approval applications. The law sets performance goals for drug reviews while raising hundreds of millions of dollars from manufacturers seeking approval of their products.

• Fees support most of the drug review process
• See related content

Drug companies and public health advocates want federal lawmakers to use reauthorization of the 20-year-old law to tackle the drug shortage problem. There are 214 drugs in short supply, according to the American Society of Health-System Pharmacists.

Provisions in the subcommittee draft of the reauthorization legislation seek to end approval delays and improve FDA programs. The bill would establish quotas for drugs in shortage and establish expedited reviews of major manufacturing changes for drugs that are, or have the potential to be, in short supply.

“In talking with patients, manufacturers and providers, they tell me it is one of the best parts of the discussion draft and it will really help with shortages,” said Rep. Joe Pitts (R, Pa.), the subcommittee’s chair.

However, the FDA already has the authority to conduct these expedited reviews, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, told the subcommittee. But officials expedite a review only if notified earlier during the review process.

214 drugs were in short supply in April 2012. 

 

to continue article...

Senate to vote on ‘the oofahs’, critical to future of FDA

The beginning of today’s Senate Health, Education, Labor and Pensions (HELP) Committee sounded like a comedy skit with Senator Mike Enzi outlining the difference between ‘the oofahs’ (PDUFA, BSUFA, MDUFMA, etc.) as relates to user fee agreements covering drugs, medical devices, generic drugs, and biosimilar products. Once the chuckles ended, the Committee called for swift passage of the legislation before the current agreement expire in September.

The user fee agreement combines accountability, transparency and added resources for FDA. “Put simply, the agreement is good for FDA; it is good for industry; and most of all, it is good for American patients.” In a press release, AdvaMed said that the device industry appreciates efforts by several Congress members who have introduced legislative proposals to give FDA the Among those testifying included officials from PhRMA, the Generic Pharmaceutical Association, AdvaMed and BIO, as well as Dr. Janet Woodcock (CDER) and Dr. Jeffrey Shuren (CDRH) from FDA.

http://www.beaker.com/blog/index.php/2012/04/03/senate-to-vote-on-the-oofahs-critical-to-future-of-fda/

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

Washington, D.C. (March 29, 2012) – Sara Radcliffe, Executive Vice President of Health at the Biotechnology Industry Organization (BIO), testified today on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA) before the Senate Health, Education, Labor and Pensions Committee in a hearing entitled, “FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients.”

In her testimony, Radcliffe expressed support for the establishment of a biosimilars user fee program as part of the Food and Drug Administration’s (FDA) implementation of a well-constructed, science-based pathway for the approval of biosimilar products that protects patient safety and preserves incentives for innovative new therapies.

“A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products,” Radcliffe testified.

click link for full article: BIO Testifies on Importance of Timely Passage of BsUFA and PDUFA

Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report

PUBLIC HEALTH

Groups Seek Congressional Action on Drug Shortages

Discounted generic drug application fees proposed as incentive to curb shortfalls.

MICHAEL FITZHUGH

The Burrill Report

“We believe appropriate mechanisms, such as a generic user fee program, could provide a crucial economic tool for FDA to provide incentives to manufacturers, and should be enacted as quickly as possible”

A group of more than 30 organizations seeking to address drug shortages in the United States has written a letter urging Congressional action to solve the problem.

The letter, sent to Senator Tom Harkin, D-Iowa, by groups representing clinicians, healthcare facilities, drug manufacturers, and patient advocates, urges Congress to consider implementing a generic user fee program in the upcoming Prescription Drug User Fee Act reauthorization, or PDUFA.

 The fees could be used to allow the U.S. Food and Drug Administration to “offer reduced application fees for products in short supply, or discounted fees if a company demonstrates that its contingency plans are sufficient to reduce the risk of a shortage if production is halted,” they suggest.

for complete article, please visit the Burrill Report link:
Groups Seek Congressional Action on Drug Shortages - 03/23/2012 - The Burrill Report