º»¹®/³»¿ë
_SLIDE_1_
Merck, the FDA, and the Vioxx Recall
_SLIDE_2_
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 $30.78 billion in sales.
Company
Sales ($bil)
Profits ($bil)
Assets ($bil)
Market value($bil)
Pfizer
40.36
6.20
120.06
285.27
Johnson & Johnson
40.01
6.74
46.66
160.96
GlaxosmithKline
34.16
6.34
29.19
124.79
Merck
30.78
7.33
42.59
108.76
_SLIDE_3_
1851
Dr. Ernst Christian Friedrich Schering begins developing and selling pharmaceutical products in Berlin. Three years later, the company opened its first production facility.
1891
Merck&Co. opens its doors in United S¡¦(»ý·«)
s were regulated by the Food and Drugs Administration (FDA).
It¡¯s taking too long times!!
` Process of approval new drugs`
_SLIDE_8_
What is the happening in drug industry
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. ¡æ 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).
¡Ú What is the PDUFA
¡æ 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.
_SLIDE_9_
The pharmaceutical industry¡¯s success in accelerating