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Nonprescription Status Considered for Chronic Disease Drugs
The FDA is considering allowing consumers to buy medications for some chronic conditions without a prescription. The agency will soon hold a two-day public meeting to evaluate whether to reclassify drugs for high blood pressure, cholesterol, migraines, and asthma so patients can get them without a prescription. Pharmacists may play a role to help patients assess their conditions with the aid of digital tools and kiosks. This reclassification should only occur if patients can diagnose their illnesses themselves and the medicine doesn't require a physician's supervision, according to some. The FDA can use its administrative powers to make many of the changes.
http://www.bloomberg.com/news/2012-03-08/fda-weighing-non-prescription-status-for-chronic-disease-drugs.html
Abbott, Amgen, AstraZeneca, Bristol-Meyers Squibb, Glaxo, Pfizer, and Novartis Sued Over Copay Discounts
Affiliates of Boston-based Community Catalyst contend that cutting copays for the drugs destroys the incentive to use cheaper generic drugs, in a suit filed today in federal court in Newark, New Jersey, against Abbott, Amgen, AstraZeneca, Bristol-Meyers Squibb, Glaxo, Pfizer, and Novartis. The companies are accused of illegally offering coupons to reduce copayments for brand name drugs. These kickbacks will increase health benefit providers' prescription drug costs by $32 billion over the next 10 years according to the plaintiffs' lawyer.
http://www.bloomberg.com/news/2012-03-07/pfizer-abbott-face-allegations-over-co-pay-coupon-promotions.html
Drug Distributor Tied to Fake Avastin Imports
Investigations involving the importation of low-cost foreign pharmaceuticals into the U.S. have identified a supply chain that may have allowed counterfeits to reach U.S. clinics. Federal officials examining the business dealings of two Canadian businessmen with long histories in the Internet pharmacy trade that delivers discounted prescription drugs from overseas to U.S. citizens have been found. One of the men acknowledges the companies shipped fake vials of Avastin late last year.
http://online.wsj.com/article/SB10001424052970203370604577261343974214110.html?mod=dist_smartbrief
'Pay-for-delay' Deals by PHARMA Companies Examined
California is the first state to examine whether pharmaceutical companies can pay competitors to NOT make or sell cheaper generic versions of their prescription drugs. The California Supreme Court has agreed to review a 10-year-old class-action lawsuit involving Cipro. The suit argues that it was illegal for Bayer to pay a competitor to stay out of the market as part of a settlement in a legal dispute over the Cipro patent. This action forced hundreds of thousands of Californians to collectively overpay millions of dollars for the drug, the lawsuit claimed. Without the competition, drug prices are inflated. Court documents show that between 1997 and the end of 2003, Bayer raised the price of Cipro by 16 percent and made a profit of about $5 billion.
http://californiawatch.org/dailyreport/state-court-examine-pay-delay-deals-drugmakers-15133
FDA to Ban Caramel Coloring in Soda?
The Center for Science in the Public Interest (CSPI) said it found unsafe levels of a chemical used to make caramel color in cans of Coca-Cola, Pepsi-Cola, Dr Pepper Snapple Group Inc.'s Dr. Pepper, and Whole Foods' 365 Cola. The group has asked the FDA to ban caramel coloring agents that contain the chemical known as 4-methylimidazole. "Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer," said CSPI executive director Michael Jacobson. The FDA considers the drinks safe and stated, "A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents."
http://www.reuters.com/article/2012/03/06/coca-cola-idUSL2E8E60BN20120306
Drug Companies Have Paid $8 Billion in Medicare and Medicaid Fraud Fines
Some of the largest pharmaceutical companies have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade. However, they are still doing business with the federal government because they are often the sole suppliers of critical products.
Companies can be fined and forced to enter corporate integrity agreements that require government oversight and a promise not to defraud the government again—a promise that often goes unkept. "We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."
The government announced in 2010 that it would start going after individuals within a company. A bipartisan bill has been introduced that would make it easier for the government to find a middle ground, saying the law now forces "the inspector general to use all-or-nothing, mandatory exclusion penalties against corporations that have committed fraud." The bill would allow the exclusion of individuals from working with the government even after they've left the company where the fraud occurred.
http://www.usatoday.com/news/washington/story/2012-03-05/health-drugmakers-fraud-fines/53372792/1
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