MARK NOVITCH - FDA DEPUTY COMMISSIONER (1981 - 1985)
Mark Novitch M.D. has been a Private Consultant in the pharmaceutical industry since 1993.
Dr. Novitch served in the senior executive positions with the Upjohn Company, a medical products company, from 1985 to December 1993, including Vice Chairman of the Board of Directors, Corporate Executive Vice President, and Corporate Senior Vice President for Scientific Administration and Corporate Vice President. He served as Vice Chairman and Chief Compliance Officer of the Upjohn Company since December 1993.
Prior to joining Upjohn in 1985, Dr. Novitch served as deputy commissioner of the federal Food and Drug Administration from 1981 to 1985. Prior to this, for 14 years, Dr. Novitch served with the FDA, and from 1983 to 1984 he served as Acting Commissioner.
He has been a Director of Guidant Corp., since 1995. He serves as a Director of KOS Pharmaceuticals Inc. He served as a Director of Neurogen Corp. since December 1993. He served as a Director of Alteon Inc., from June 1994 to July 21, 2006. He served as a Director of Calypte Biomedical Corp., since September 1995. Dr. Novitch served as an Adjunct Professor at George Washington University Medical Center from July 1997 to June 2001. From October 1994 to June 1997 Dr. Novitch served as a Professor of Health Care Sciences at George Washington University Medical Center. For seven years, Dr. Novitch was on the faculty at Harvard Medical School. Dr. Novitch received his A.B. from Yale University, and his M.D. from the New York Medical College.
1982 Tylenol Murder Crisis
October 2, 1982
Dr. Mark Novitch, deputy FDA commissioner, said in Washington the contamination appeared limited to the Chicago area, where all the deaths occurred. But he said the agency was urging Americans not to take Extra- Strength Tylenol for now. The advisory does not apply to Extra-Strength Tylenol in tablet form.
Novitch said the FDA believed the contamination occurred after the bottles reached store shelves, not in the "distribution chain." He said the bottles are wrapped in plastic and put in cartons as they leave the factory and remain that way until the retailer gets them.
"If a retailer had received an open package in which a bottle had been removed and tampered with, it would become immediately obvious," Novitch said.
Novitch's statement that damaged packaging would have lead anyone to believe the Tylenol capsules had been tampered with was ridiculous. The packaging was never intended to thwart tamperng, and nobody ever considered that opened or damaged packaging would have been any cause for concern.
Any warehouse worker who noticed damaged packaging would have just taped up the package if necessary and then loaded it on the delivery truck. Any stockboy who received a damaged package would have simply ensured no product was missing, before signing the invoice and then ripping the package open so the contents could be placed on the store shelves.
Novitch Solves the Crime in Just Three Days
Three days after it was determined that seven people died after swallowing cyanide laced Tylenol capsules, Dr. Mark Novitch, deputy commissioner of the FDA, was already promoting the rhetoric designed to get Johnson & Johnson off the hook. During a news conference in Washington DC, Novitch stated that federal officials believed the contamination occurred after the bottles reached store shelves and not in the ''distribution chain.''
Novitch said he suspected that someone took bottles of Extra-Strength Tylenol capsules off the shelves in Chicago retail stores, put the cyanide inside them, and then replaced the bottles on the shelves. It's unlikely, he said, that the bottles were contaminated when they reached the stores.
Novitch's statements countered statements made by Attorney General Tyrone Fahner who said the Tylenol capsules were probably tampered with during distribution. A few days later, Fahner changed his story and went along with the bogus "approved theory" promoted by J&J and FDA.
Novitch Admits to FDA Incompetence
About one week after the 1982 Tylenol murders, Novitch had this to say about the FDA's ability to keep people from poisoning medicine:
"The frightening truth is that there is no way to protect the public from people who do such things." - Poison Madness in the Midwest
Actually, the FDA could have made it impossible to contaminate Tylenol by putting poison into the easily adulterated capsules, as the Tylenol killer had done. They simply needed to ban capsules.
After Tylenol capsules were filled with cyanide yet again, in 1986, in the same way they were tampered with 1982, the FDA finally banned OTC drugs in capsule form. For Diane Elsroth, the ban came four years too late. She died after ingesting two cyanide laced Extra-Strength Tylenol capsules on February 8, 1986, .
The FDA Exonerates Johnson & Johnson
Twenty-three days after it was learned that cyanide laced Extra-Strength Tylenol had been used as a murder weapon, the FDA cleared Johnson & Johnson of any responsibility for the tampering. The FDA determined that the tampering had occurred locally, at the retail stores, and they officially cleared Johnson & Johnson and their subsidiary McNeil Consumer Products of any responsibility for the contamination of the Tylenol capsules that killed seven Chicago area residents.