Extending the term of exclusive access to clinical trial data will raise drug costs in the short term but also help approve 200 extra drugs and result in greater life expectancy in the long term, according to a study in the Jan. 2011 issue of Health Affairs.
Pharmaceutical companies and generic drug manufacturers have been at odds over regulations about "data exclusivity," the period of time before generic manufacturers can make use of valuable clinical trial data, according to the release. 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. Companies can receive three-year and six-month extensions in certain circumstances.
Researchers estimated that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent. According to the report, the longer term would also lead to 228 additional drug approvals over the next 50 years and an increase of 1.7 months in average life expectancy.
Read the study in the Jan. 2011 issue of Health Affairs (login required).
Read more on clinical trials:
-Femoral Nerve Blocks Improve Analgesia Outcomes Following Total Knee Arthroplasty
-Methadone Reduces Postoperative Pain in Complex Spine Surgery Patients
-Study: Morphine-Like Drug Stronger, Longer-Lasting Than Standard Morphine
Pharmaceutical companies and generic drug manufacturers have been at odds over regulations about "data exclusivity," the period of time before generic manufacturers can make use of valuable clinical trial data, according to the release. 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. Companies can receive three-year and six-month extensions in certain circumstances.
Researchers estimated that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5 percent. According to the report, the longer term would also lead to 228 additional drug approvals over the next 50 years and an increase of 1.7 months in average life expectancy.
Read the study in the Jan. 2011 issue of Health Affairs (login required).
Read more on clinical trials:
-Femoral Nerve Blocks Improve Analgesia Outcomes Following Total Knee Arthroplasty
-Methadone Reduces Postoperative Pain in Complex Spine Surgery Patients
-Study: Morphine-Like Drug Stronger, Longer-Lasting Than Standard Morphine