Merck, the FDA, and the Vioxx Recall

목차

1. Introduction of Merck
2. History of the Merck
3. Organization of Merck
4. Main value of Merck
5. Products of Merck
6. Government Regulation of Prescription Drugs
7. What is the happening in drug industry?
8. Influence at the Top
9. The Blockbuster Model
10. Direct-to-Consumer Advertising
11. Merck Research
12. VIGOR
13. Kaiser/ Permanente
14. APPROVe

본문내용

Introduction of Merck
* In 2005 the company ranked fourth in sales, after Pfizer, Johnson & Johnson, and GlaxoSmithKline.
* In assets and market value, it ranked fifth. However, Merck ranked first in profits, earning $7.33 billion on $30.78 billion in sales.

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The Result of PDUFA
In the 1980’s, the drug industry and some patient advocate had criticized the FDA for being too slow to approve new medicines. → Each month an average drug spent under review represented $41.7 million in lost revenue.
In 1992, U.S. Congress passed the prescription Drug User Fee Act (PDUFA).
★ What is the PDUFA??
→ PDUFA allowed the Food and Drugs Administration (FDA) to collect fees from drug manufacturers to fund the new drugs approval process.
Between 1993 to 2001, the FDA received around $82.5 million in such fees from drug makers seeking approval.
After the FDA shortened the approval time, the percentage of drugs recalled following approval increased from 1.56% for 1993~1996 to 5.35% for 1997~2001.
The pharmaceutical industry’s success in accelerating the approval of new drugs reflected its strong presence in Washington

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In August 2004, Dr. David Graham, scientist at the FDA A study of 1.4 million patients
in Kaiser health maintenance organization in CA Patients on high doses of Vioxx had three times the rate of heart attacks as patients on Celebrex(Pfizer) But Merck discounted this finding

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