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Former HHS Chief Urges Crackdown on Compounding Pharmacies
Former HHS Secretary Tommy Thompson has announced the formation of a working group to work for greater oversight of compounding pharmacies. The Working Group on Pharmaceutical Safety is formed because of growing scrutiny of state-regulated compounding manufacturers who tailor drugs' dosages or other properties to fit specific patient needs. Thompson said the group would work for changes designed to avert a repeat of the outbreak. Sarah Sellers is a co-leader of the group and works with patient-rights advocates, FDA-approved pharmaceutical companies, and other medical groups.
http://thehill.com/blogs/regwatch/healthcare/306497-tommy-thompson-forms-group-to-push-for-compounding-drug-restrictions
U.S. Dept. of Justice Sues to Keep Tinton Falls-based Compounding Pharmacy Closed
The Department of Justice is seeking an injunction to keep Med Prep Consulting Inc. of Tinton Falls, New Jersey closed following a discovery of mold in several intravenous bags it had prepared. The complaint against Med Prep Consulting and Gerald Tighe, its owner, cited numerous health violations, drug misbranding, and years of repeated failures to comply with warnings as evidence of wrongdoing. The government is seeking to keep Med Prep closed permanently unless the company can prove it has complied with health and safety guidelines under the Federal Food, Drug, and Cosmetic Act.
http://www.nj.com/business/index.ssf/2013/06/us_dept_of_justice_sues_to_kee.html
Infusion Pump Linked to 14 Deaths Recalled
Four discovered flaws found in SynchroMed infusion pumps have led to 14 patient deaths, spurring U.S. regulators to issue their most serious recall on the implantable device. Medtronic is the world's largest heart device maker. Each flaw found was deemed a Class 1 recall by the FDA, denoting potential life-threatening issues.
http://www.bloomberg.com/news/2013-06-27/medtronic-recalls-infusion-pump-linked-to-14-deaths.html
Fake Weight-loss Study Leads to Man Sentenced to Six Years in Prison
A 51-year-old Arvada man has been sentenced to six years in federal prison. The sentence results from him scamming multiple people who thought they were participating in a health study tracking weight-loss. Between April 2006 and July 2008, he defrauded people throughout the U.S. by having them pay money to participate in a bogus clinical study. He asked the participants to pay a $144 or $150 "one-time refunded deposit" to be studied while taking one of two weight-loss products that were just placebos.
http://www.denverpost.com/breakingnews/ci_23531210/arvada-man-spend-six-years-prison-fake-weight
Bystolic-promoting Prescribers Make Money From Drugmakers
When Bystolic hit the market in 2008, there were many generics. Its maker, Forest Laboratories, launched a promotional assault on the group in the best position to determine Bystolic's success: those in control of prescription pads. Forest Labs flooded the offices of health professionals with drug rep, and it hired doctors to persuade their peers to choose Bystolic. This was done even though the drug had not been proven to be more effective than its competitors. This worked, as in 2012 the sales of Bystolic reached $348 million, almost double its total from two years earlier.
http://www.propublica.org/article/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers
India Cutting Drug Prices with Price Caps
Many drugs could become a lot cheaper as the government plans to notify price caps for 51 essential drugs under a new drug price control order that was enforced last month. With this second lot of notifications by the National Pharma Pricing Authority, the brands selling the most expensive antibiotics would have to cut their prices by 30% to 60%. The government previously notified the prices of 150 drugs, in accordance with a market-based pricing formula. The decision to notify the second lot of essential drugs was taken at a recent meeting.
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/blood-pressure-drugs-and-antibiotics-to-be-cheaper-as-government-plans-to-notify-price-caps/articleshow/20735889.cms
United Kingdom Cutting Prices Up to 20% on Some Medicines
The U.K. Department of Health is planning to reduce the prices of many brand-name medicines as the government plans to save 11.5 billion pounds ($18 billion) in the 2015-2016 spending year. These new cuts would apply to drugs not already covered by an existing agreement between manufacturers and the government, known as the Pharmaceutical Price Regulation Scheme, or PPRS. The government National Health Service and the largest payer for medicines in the U.K. said it will also continue negotiating with the industry over the PPRS.
http://www.bloomberg.com/news/2013-06-20/price-cuts-of-up-to-20-sought-by-u-k-on-some-medicines.html
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