Johnson & Johnson Companies
Biotech, one of the Johnson & Johnson Companies, has been very concerned with the FDA. The FDA has started to get very strict on what drugs they let in the market; since, the incidents with other well known drugs such as Phen-fen and Lotronex were pulled from the market for safety concerns. They have started to get "gun-shy" with putting other drugs on the market.
The FDA will be a big future challenge for the medical companies incorporated with Johnson & Johnson Companies. Biotech suffered when the FDA made them do more clinical studies on the allergy drug, Soltara, which was their biggest drug to come out this year. Studies recognized that a condition called "QT Prolongation", which can lead to irregular heart beat, is common in antihistamines. In past studies that were done, they discovered that 2 of the 3 concerns from the FDA were present, but there were no signs of "QT prolongation."
Johnson & Johnson (JNJ.N) and its smaller partner Alkermes Inc. (ALKS.O) said in early July the FDA rejected their request to market an inject able version of J&J's lucrative schizophrenia treatment Risperdal, sending Alkermes' stock plunging 68 percent. An analyst report at the time cited an increased risk of cancer found in testing of the drug in rodents -- even though the drug survived three phases of clinical trials in humans without raising a significant cancer concern.
This was a major set back for the company as well as a future challenge. It may be years before they can finish all of the studies and put the drug on the market. The FDA has even requested drugs be tested that have been thoroughly tested already, if they are in any category that has experienced problems. This creates money problems in most...