Proton Pump Inhibitors - CME Conferences
Proton Pump Inhibitors - CME Conferences Proton Pump Inhibitors - CME Conferences
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 FDA Hatch-Waxman Amendments to FFD&C Act - 1984 • Considered one of the most successful pieces of legislation ever passed • Created the generic drug industry • Increased availability of generics • 1984 12% prescriptions were generic • 2000 44% prescriptions were generic - yet only 8% of revenue for prescription drug • 2009 71% prescriptions were generic • 2010 78% prescriptions were generic • Compromise legislation to benefit both brand and generic firms Center for Drug Evaluation and Research FDA Hatch-Waxman Amendments to FFD&C Act - 1984 • Allowed generic firms to rely on findings of safety and efficacy of innovator drug after expiration of patents and exclusivities (do not have to repeat expensive clinical and preclinical trials) • Allowed patent extensions and exclusivities to innovator firms Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
6 th Annual Primary Care Spring Conference Thursday, April 12, 2012 Innovator Incentives (Patents) FDA • Prior to 1984, a patent would run for 17 years from issue date or 20 years from filing • W/H set to restore some incentive for innovation because pre-market approval requirements have increased • W/H may restore up to 5 years not to exceed 14 years from the product’s approval date Center for Drug Evaluation and Research Innovator Incentives(cont.) FDA • URAA* (June 8, 1995) made all patents in force or filed as of this date have the longer term of 17 years from issuance or 20 years from filing • All patents filed after June 8, 1995 have an expiration date of 20 years from filing – *Uruguay Round Agreements Act Center for Drug Evaluation and Research Wayne Weart, Pharm D Cost Effective Rx
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6 th Annual Primary Care Spring Conference Thursday, April 12, 2012<br />
FDA<br />
Hatch-Waxman Amendments<br />
to FFD&C Act - 1984<br />
• Considered one of the most successful pieces of<br />
legislation ever passed<br />
• Created the generic drug industry<br />
• Increased availability of generics<br />
• 1984 12% prescriptions were generic<br />
• 2000 44% prescriptions were generic - yet only<br />
8% of revenue<br />
for prescription drug<br />
• 2009 71% prescriptions were generic<br />
• 2010 78% prescriptions were generic<br />
• Compromise legislation to benefit both brand and<br />
generic firms<br />
Center for Drug Evaluation and Research<br />
FDA<br />
Hatch-Waxman Amendments<br />
to FFD&C Act - 1984<br />
• Allowed generic firms to rely on findings of<br />
safety and efficacy of innovator drug after<br />
expiration of patents and exclusivities (do not<br />
have to repeat expensive clinical and preclinical<br />
trials)<br />
• Allowed patent extensions and exclusivities to<br />
innovator firms<br />
Center for Drug Evaluation and Research<br />
Wayne Weart, Pharm D<br />
Cost Effective Rx
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