Navigation Links
How do data exclusivity periods affect pharmaceutical innovation?
Date:1/6/2011

LOS ANGELES, Calif. January 6, 2011 Pharmaceutical companies and generic drug manufacturers have long been at odds over regulations about "data exclusivity," the period of time before generic manufacturers can make use of valuable clinical trial data.

A new study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

"Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations," explained Dana Goldman, lead author, director of the Schaeffer Center for Health Policy and Economics at USC and Norman Topping Chair in Medicine and Public Policy at USC.

The pharmaceutical companies that introduce new drugs are currently granted five years of exclusive access to the clinical trial data they submit during the approval process. An extension of three years is available if new applications arise and a six month extension is granted if the drug is approved for use in pediatric populations.

In 2007, the National Academies Committee on Science, Engineering and Public Policy called for extending this "data exclusivity" term to the longer period used in Europe, ten to 11 years. But generic manufacturers have argued for shorter limits so that they can bring less expensive versions of drugs to patients sooner.

"Unfortunately, the health policy literature contains no information about the effects such a policy would have on innovation, population longevity and social welfare," said Darius Lakdawalla, research director at the Schaeffer Center at USC and associate professor in th
'/>"/>

Contact: Suzanne Wu
suzanne.wu@usc.edu
213-740-0252
University of Southern California
Source:Eurekalert

Page: 1 2

Related medicine news :

1. Gene Activity May Affect Acute Myeloid Leukemia Outcome
2. Vitamin D and parathyroid hormone levels may not affect cardiovascular mortality
3. Depression During Pregnancy Might Affect Baby
4. How MS Affects Kids May Differ by Race
5. Marital Status May Affect Kidney Transplant Decision
6. Research Finds Not All HIV Affects Immune System Same Way
7. Working With Pesticides May Affect Memory and More
8. Sleepless soldiers: Study suggests that military deployment affects sleep patterns
9. Trust in Doctor May Affect Reaction to Medical Error
10. Too Much Hygiene May Affect Immune System, Study Suggests
11. Social Class May Affect Outcome of Depression Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy Champagne ... highest annual revenues in the past three years. Today, the ... dresses. , According to the sales manager of the company, ... them in 2015. This point can be reflected on the ...
(Date:1/22/2015)... Payday lending practices in four southern states ... distress to the states that permit them, according to ... on Race and Wealth. , While they generate hundreds ... at the same time substantially depress economic activity, according ...
(Date:1/22/2015)... JJsHouse.com is a famous dress online store for ... its latest collection of wedding dresses , and launches ... is the wedding dress on your big day; the wedding ... Every bride wants to find the most suitable wedding dress. ...
(Date:1/22/2015)... Step into a macabre world where plants ... Virginia. Wicked Plants, the Museum’s latest featured exhibition, opens ... carnivorous and diabolical plants inside of a dilapidated, Victorian ... biochemical, physical and neurological processes between botanicals and the ...
(Date:12/26/2014)... It is said that nothing makes a lady feel ... wedding dress supplier, shows its new selection of navy ... , UWDress.com’s navy cocktail gowns are the cornerstones of ... fashion styles. Simple dresses in bright neon colors can be ...
Breaking Medicine News(10 mins):Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2Health News:Wicked Plants are taking over the Science Museum of Virginia 2Health News:UWDress.com Shows Its New Navy Cocktail Dresses For 2015 2
... and Industry Thought Leader Joins Healthcare ... Management Consulting Practice, ... to announce the appointment of Ogan Gurel, M.D. as a ... have Dr. Gurel join our team," said Vip Jain - ...
... BET Networks, national HIV/AIDS,public awareness initiative Rap-It-Up returns ... health forums throughout New York City and Newark,N.J., to ... young adults; as well as the rise of HIV/AIDS ... organization Hip,Hop 4 Life and local radio station Hot ...
... to succeed in reducing prevalance of obesity,among children ... intervention and,education, MEMPHIS, Tenn., Nov. 7 ... at St. Jude Children,s,Research Hospital is the first ... in reducing the prevalence of overweight children, according ...
... businesses for its commitment to building a culture of ... ... The American Heart Association,recently recognized Regence as a Start! ... in the workplace and helping,employees live healthier lives. The company ...
... Million ... Million, SUNNYVALE, Calif., Nov. 7 Accuray,Incorporated (Nasdaq: ... announced financial results for the first quarter of fiscal 2008,ended ... 2008, Accuray reported record total,revenue of $48.6 million, up 48 ...
... ... Exploration Process, GERMANTOWN, Md., Nov. ... company focused on,developing and commercializing novel anti-infective products, announced an,agreement ... Company,s largest equity shareholders, raising up to $10 million in,cash. ...
Cached Medicine News:Health News:XRoads Solutions Group Appoints Dr. Ogan Gurel as Managing Director 2Health News:BET Networks' Award-Winning Rap-It-Up HIV/AIDS Campaign Returns to New York City for The Youth Empowerment Tour on November 13-16 2Health News:BET Networks' Award-Winning Rap-It-Up HIV/AIDS Campaign Returns to New York City for The Youth Empowerment Tour on November 13-16 3Health News:St. Jude Program Reduces Weight Gain in Young African-American Girls 2Health News:St. Jude Program Reduces Weight Gain in Young African-American Girls 3Health News:American Heart Association Award Recognizes Regence as a Start! Fit-Friendly Company 2Health News:American Heart Association Award Recognizes Regence as a Start! Fit-Friendly Company 3Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 2Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 3Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 4Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 5Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 6Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 7Health News:Accuray Reports Record Revenue in First Quarter of Fiscal 2008 8Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 2Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 3Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 4Health News:MiddleBrook Pharmaceuticals Raises Up to $10 Million from Deerfield Management 5
(Date:1/23/2015)... , Jan. 23, 2015  CytoSorbents Corporation (NASDAQ CM: ... CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation ... receipt of $385,642, net of transaction costs, in ... Technology Business Tax Certificate Transfer Program sponsored by ...
(Date:1/23/2015)... BOSTON , January 23, 2015 Heptares ... is delighted to announce that the Malcolm Campbell ... Congreve (Vice President of Chemistry), Fiona Marshall ... (Chief Executive Officer and co-founder) for the seminal contributions to ...
(Date:1/22/2015)... Colo. , Jan. 22, 2015  BiOptix is pleased ... as Vice President of Chemistry and Biochemistry. Scott joins ... Pharmaceuticals, AstraZeneca Pharmaceuticals, and Amgen throughout the course of ... development. "Scott is a nationally recognized thought ...
Breaking Medicine Technology:CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 2CytoSorbents Receives $385,000 in Non-Dilutive Funding from the New Jersey Technology Business Tax Certificate Transfer Program 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 2Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 3Heptares Scientists to Receive the Malcolm Campbell Memorial Prize for 2015 in Recognition of Their Outstanding Contribution to GPCR Drug Discovery 4BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2
... NeurogesX, Inc. (Nasdaq: NGSX ), a biopharmaceutical ... announced that it has entered into a $20 million ... HTGC).  The loan agreement includes both a $5 million ... term loan. Proceeds are expected to be ...
... Aug. 8, 2011 Global Health Ventures Inc. ... on sublingual drug delivery announced today that their August ... and CEO, is available for on-demand viewing. ... watch event now" button. Their presentation will ...
Cached Medicine Technology:NeurogesX, Inc. Secures $20 Million Debt Facility 2NeurogesX, Inc. Secures $20 Million Debt Facility 3NeurogesX, Inc. Secures $20 Million Debt Facility 4Global Health Ventures August 4th Investor Presentation Now Available for On-demand Viewing at RetailInvestorConferences.com 2
... Bio-Quant S. typhi rapid test is ... The test employs a conation of ... polyclonal antibody immobilized on the solid ... typhi,antigen associated Salmonella typhi (typhoid) infection ...
... Mono is an immunochromatographic in vitro ... with,infectious mononucleosis infection.,Infectious mononucleosis (IM) is ... of IM is based on detection ... such as the,heterophile antibodies present in ...
OneStep Midstream Urine hCG Pregnancy InstaTest is a test kit for the determination of hCG(Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a visual, qualitative resu...
... Myoglobin Insta Test is an ... test. It is designed for ... serum specimens. The presence of ... ng/mL or higher can be ...
Medicine Products: