Articles Posted in Pharma

There is an important article in today’s Wall Street Journal overviewing the significant increases in prices of drugs by the pharmaceutical manufacturers–despite rising criticism by patients, doctors, politicians and healthcare payers. Some think they have priced themselves out. Others, cited in this article think the companies still have the power to continue to raise prices. See the Journal article here http://www.wsj.com/articles/drugmakers-raise-prices-despite-criticisms-1452474210.

Many of the price increases add thousands of dollars to drugs that are already over-priced and exceed ability to pay. Vanda Pharmaceuticals Inc raised the price of its drug Hetlioz which treats a sleep disorder in blind people. It went up 10% to $148,000 per year. That is 76% higher than it was when introduced n 2014. Pfizer has raised list prices an average of 10.6% on over 60 products. Prices for eight of them went up 20%.

U.S. spending on prescription drugs continues to rise up 12.2% in 2014.

A former paralegal from Sanofi, Diane Ponte has filed a whistleblower action alleging that Sanofi paid tens of millions of dollars to pharmacy groups and hospitals, through consultants Accenture and DEloitte using contracts that looked legitimate but which were in fact inducements to buy Sanofi products. Ultimately the kickbacks were used to spike sales of diabetes drugs in the States, according to the suit. The suit also alleges that about $1 billion is “unaccounted for” at the company.

The lawsuit, filed in New Jersey Superior Court in Newark, names Sanofi, Viehbacher and several other top executives, CNBC reports.

Two years ago, Sanofi paid $109 million to settle U.S.  allegations that it had provided free syringes of its arthritis injection Hyalgan to doctors to get them to prescribe the medication. The suit said the doctors then charged payers the regular rate for the doses they received at no cost. Giving meds away can be considered an inducement to prescribe and then charge federal programs for drugs that might not otherwise have been prescribed.

Omnicare is the nation’s largest provider of pharmaceuticals and pharmacy services to nursing homes and it is paying over $124 million for offering improper financial incentives to skilled nursing homes in return for their selecting Omnicare to supply their drugs to elderly Medicare and Medicaid patients.

The complaint alleged that Omnicare submitted false claims by entering into below-co Continue reading

Prosecutors for Uncle Sam have charged that Swiss drug maker Novartis have paid massive kickbacks to 26,997 physicians including money, free dinners and entertainment to steer patients to Starlix and two of its hypertension pills, Lotrel and Valturna.

Under the Stark Act, an Anti-kickback law, it is not legal for a drug company to pay doctors to induce them to write prescriptions for the company’s drugs that are reimbursable under federal health care programs. Continue reading

The United States Food and Drug Administration (FDA) is now investigating reports of serious testosterone side effects and now major lawsuits have been filed against Abbott labs and AbbVie Inc. The suits allege that the companies which make AndroGel testosterone replacement hid major risks.  According to reports men  between the ages of 50 and 65, are claiming that they suffered serious side effects as a result of using AndroGel. Among the alleged side effects were heart attacks, stroke and a mini-stroke.

According to the case of  Aurecchia v. AbbVie Inc.,case number 1:14-cv-772, filed in Chicago,  AbbVie and Abbott “misrepresented that AndroGel is a safe and effective treatment for hypogonadism or ‘low testosterone,’ when in fact the drug causes serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.” Continue reading

Pharma companies Endo Pharmaceuticals and Endo Health solutions will pay $192.7 million to resolve criminal and civil charges over their marketing of Lidoderm, a topical patch to relieve pain.

One it is applied, Lidoderm causes a loss of feeling. It is often used with surgery in treatment of emergency heart rhythm problems. It was only approved by the FDA for relief of post herpetic neuralgia.  According to Uncle Sam, the companies marketed the product for off label uses. Fraudulent bills were submitted to Medicare and Medicaid which were the false claims. Continue reading

The Food and Drug Administration is now concerned about the safety of drugs manufactured in India and is examining the products flooding the U.S. markets as a result of safety lapses, falsified drug test results and the selling of fake medicines.

India’s pharmaceutical companies supplies over 40 percent of the over-the-counter medicines in the U.S. The heightened concern by U.S. regulators stems from recent findings that some drugs entering our market were adulterated including the acne drug Acutane and the pain drug Neurontin. The generic versions of these drugs were banned from being imported from India.

Ranbaxy, India’s largest drug manufacturer pleaded guilty to feloney charged and paid a $500 million charge last year after being caught falsifying information to the F.D.A. Continue reading

Carefusion will pay $40.1 million to settle a government lawsuit and whistleblower allegations under the False Claims Act, that the company paid kickbacks to increase sales of its pre-surgical skincare product ChloraPrep.

In addition, the company is alleged to have promoted the product unlawfully for uses not approved by the FDA. In this situation it is alleged that it was marketed for pre-surgical treatment despite the fact that the FDA only approved it for preparation of a patient’s skin prior to surgery or injection.

The whistleblower in this case is  Dr. Cynthia Kirk a former vice president of regulatory affairs. She will receive $3.26 million as her qui tam award pursuant to the False Claims Act.

The whistleblowers at Johnson & Johnson who helped the federal government obtain $2.2 billion in fines from the company for bribing physicians, pharmacies and long term care managers to encourage sales of antipsychotic drugs will receive more than $20 million each.

The first who filed will each get $29 million from the settlement and the sixth will receive over $20 million.

Whistleblowers still have to pay their legal counsel and taxes. The lead whistleblower in the J& J Risperdal case Judy Doethert wore hidden microphones to J&J sales meetings .

The U.S. Food and Drug Administration is now warning consumers against a dietary body building supplement Mass Destruction found to contain a synthetic anabolic Steroid. The alert came just after a death which has been blamed on the product.

According to the FDA liver injury is a side affect of steroid use, others being testicle shrinkage, infertility, breast enlargement and increased risks for heart attach and stroke.

Mass Destruction in marketed through Blunt Force Nutrition. The manufacturer was not identified.