Company type | Subsidiary (of Johnson & Johnson) |
---|---|
Industry | |
Founded | Merger of Ortho Pharmaceutical & McNeil Pharmaceutical (1993 ) |
Products | See list of Johnson & Johnson products |
Website | jnj |
Ortho-McNeil Pharmaceutical (now operating under Janssen Pharmaceuticals) was a pharmaceutical company based in Raritan, New Jersey, that was formed from the merger of Ortho Pharmaceutical and McNeil Pharmaceutical in 1993. [1] Both of these pharmaceutical companies were pioneers and leaders in areas such as pain management, acid reflux disease, and infectious diseases. [2]
Ortho-McNeil and Janssen Pharmaceuticals together composed the Ortho-McNeil-Janssen group within Johnson & Johnson prior to a decision to operate under the Janssen Pharmaceuticals name in 2011. [3]
Amongst its many prescription drugs are:
In 2010, Ortho-McNeil pled guilty in U.S. District Court to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was charged with using a program called "Doctor for a Day" to promote Topamax to psychiatrists for treatment of mental health conditions, despite never applying for FDA approval of Topimax for any psychiatric indication. The company was sentenced to pay a fine of $6.14 million. [4]
Ortho-McNeil's parent company, Johnson and Johnson, also paid $75.37 million to resolve civil allegations under the False Claims Act that it caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not FDA approved. [4]
Ortho-McNeil was found liable in two 2013 civil suits by women who gave birth to children with birth defects after taking Topamax while pregnant. The jury found that they negligently failed to warn the patients and their doctors of the risks associated with Topamax when used by patients during pregnancy. [5] They awarded $11 million in damages to one family [6] and $4 million to the other. [5]
As a result of these and other patient reports, the FDA ordered that a warning be added to the prescribing information for Topamax detailing the risk of birth defects such as cleft lip and cleft palate. [5]
Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a component of the Dow Jones Industrial Average, and the company is ranked No. 40 on the 2023 Fortune 500 list of the largest United States corporations. In 2023, the company was ranked 40th in the Forbes Global 2000. Johnson & Johnson has a global workforce of approximately 130,000 employees who are led by the company's current chairman and chief executive officer, Joaquin Duato.
Topiramate, sold under the brand name Topamax among others, is a medication used to treat epilepsy and prevent migraines. It has also been used in alcohol dependence and essential tremor. For epilepsy this includes treatment for generalized or focal seizures. It is taken orally.
The pharmaceutical industry is an industry involved in medicine that discovers, develops, produces, and markets pharmaceutical goods for use as drugs that function by being administered to patients using such medications with the goal of curing and/or preventing disease. Pharmaceutical companies may deal in "generic" medications and medical devices without the involvement of intellectual property, in "brand" materials specifically tied to a given company's history, or in both within different contexts. The industry's various subdivisions are all subject to a variety of laws and regulations that govern entire financial processes including the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020, in total, and this showed a compound annual growth rate (CAGR) of 1.8% given the results of recent events.
Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.
Adrafinil, sold under the brand name Olmifon, is a wakefulness-promoting medication that was formerly used in France to improve alertness, attention, wakefulness, and mood, particularly in the elderly. It was also used off-label by individuals who wished to avoid fatigue, such as night workers or others who needed to stay awake and alert for long periods of time. Additionally, the medication has been used non-medically as a novel vigilance-promoting agent.
Ofloxacin is a quinolone antibiotic useful for the treatment of a number of bacterial infections. When taken by mouth or injection into a vein, these include pneumonia, cellulitis, urinary tract infections, prostatitis, plague, and certain types of infectious diarrhea. Other uses, along with other medications, include treating multidrug resistant tuberculosis. An eye drop may be used for a superficial bacterial infection of the eye and an ear drop may be used for otitis media when a hole in the ear drum is present.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Takeda Oncology is a biopharmaceutical company based in Cambridge, Massachusetts. It is a fully owned subsidiary of Takeda Pharmaceutical.
Johnson & Johnson Innovative Medicine is a Belgian pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.
The United States Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) provides the FDA with a specific office to conduct and coordinate its criminal investigations.
Ortho Pharmaceutical was initially formed in the United States in 1931 as a subsidiary of Johnson & Johnson to market the first prescription spermicidal contraceptive jelly, Ortho-Gynol.
Phentermine/topiramate, sold under the brand name Qsymia, is a combination drug of phentermine and topiramate used to treat obesity. It is used together with dietary changes and exercise. If less than 3% weight loss is seen after 3 months it is recommended the medication be stopped. The weight loss is modest. Effects on heart related health problems or death is unclear.
Dapoxetine, marketed as Priligy, among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men 18–64 years old. Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. As a member of the selective serotonin reuptake inhibitor (SSRI) family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant.
Actelion Pharmaceuticals Ltd. is a pharmaceuticals and biotechnology company established in December 1997, headquartered in Allschwil near Basel, Switzerland.
Health care fraud includes "snake oil" marketing, health insurance fraud, drug fraud, and medical fraud. Health insurance fraud occurs when a company or an individual defrauds an insurer or government health care program, such as Medicare or equivalent State programs. The manner in which this is done varies, and persons engaging in fraud are always seeking new ways to circumvent the law. Damages from fraud can be recovered by use of the False Claims Act, most commonly under the qui tam provisions which rewards an individual for being a "whistleblower", or relator (law).
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
Founded in 1990, Insys Therapeutics was an American specialty pharmaceutical company based in Chandler, Arizona. Its main product was Subsys, a sublingual liquid form of the drug fentanyl. Fentanyl is an extremely fast-acting and powerful opioid used to relieve peaks of pain in cancer patients.
Erdafitinib, sold under the brand name Balversa, is an anti-cancer medication. It is a small molecule inhibitor of fibroblast growth factor receptor (FGFR) used for the treatment of cancer. FGFRs are a subset of tyrosine kinases which are unregulated in some tumors and influence tumor cell differentiation, proliferation, angiogenesis, and cell survival. Astex Pharmaceuticals discovered the drug and licensed it to Janssen Pharmaceuticals for further development.
Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after Franklin v. Parke-Davis, in which a court ruled off-label marketing a violation of the False Claims Act.