Most Clicked FDLI SmartBrief Stories


1. DoJ files $3.35B lawsuit against Novartis

FDLI SmartBrief | Jul 02, 2015

A lawsuit by the U.S. Department of Justice alleges that Novartis used kickbacks to persuade specialty pharmacies to increase prescriptions for Exjade, which reduces iron levels in transfusion patients, and kidney transplant treatment Myfortic. The government seeks $1.52 billion in damages and $1.83 billion in fines. The trial is expected to begin in November. The Wall Street Journal (tiered subscription model) (06/30) Bloomberg (07/01)


2. Purdue Pharma withdraws FDA application for abuse-deterrent OxyContin drug

FDLI SmartBrief | Jul 01, 2015

Purdue Pharma has withdrawn its FDA application to market its reformulated OxyContin pain treatment because it needs additional time to evaluate and review its research information related to overdose, abuse, addiction and death risks of the medication. An FDA committee was originally scheduled to meet next week to assess whether the updated version could lessen abuse rates by pain patients. U.S. News & World Report (06/30)


3. FDA faces lawsuit related to Gilead's hepatitis C treatments

FDLI SmartBrief | Jun 30, 2015

The Treatment Action Group and Yale University's Global Health Justice Partnership filed a lawsuit against the FDA to speed up the disclosure of the clinical research information that backed up the approval of Gilead Sciences' hepatitis C drugs Sovaldi and Harvoni. In a complaint submitted to a federal court in New Haven, Conn., the groups said doctors and patients need more data to make decisions about using the drugs, which are costly and not always covered by insurance. The groups asked Gilead for the information and were ignored, and they were told by the FDA that a decision on whether to disclose the data could take up to two years. Reuters (06/29)


4. U.S. to release 120 medtech classes from premarket requirements

FDLI SmartBrief | Jul 01, 2015

In a new final guidance document, the FDA said it would exclude 120 classes of medtech products from premarket review and notification requirements. The FDA said companies will not be required to file a 510(k) and will not be subject to 510(k) requirements. "The FDA believes devices identified ... are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness," according to the guidance. Regulatory Focus (06/30)


5. FDA-approved drug could help people with alcohol, cocaine addiction, study says

FDLI SmartBrief | Jun 29, 2015

A study in Molecular Psychiatry said the FDA approved-drug isradipine, developed for treating high blood pressure, shows promise in addressing alcohol and cocaine addiction. University of Texas researchers administered the drug to addicted rats and found it could condition the brain and eliminate unconscious triggers related to alcohol and cocaine addiction, potentially preventing relapse. International Business Times (06/26)


6. EU panel backs approval of 10 drugs

FDLI SmartBrief | Jun 29, 2015

The European Medicines Agency's Committee for Medicinal Products for Human Use recently endorsed the approval of 10 drugs. Among the drugs receiving endorsement are Alexion Pharmaceuticals' Strensiq, or asfotase alfa, for juvenile-onset hypophosphatasiais; Synageva BioPharma's Kanuma, or sebelipase alfa, for lysosomal acid lipase deficiency; Novartis' Farydak, or panobinostat, for relapsed and/or refractory multiple myeloma, and its basal cell carcinoma drug Odomzo, or sonidegib; and CSL Behring's Respreeza for alpha1-proteinase inhibitor deficiency. Several generic and "hybrid" drugs were also endorsed. PharmaTimes (U.K.) (06/28)


7. Unapproved Rx ear drops targeted by FDA

FDLI SmartBrief | Jul 02, 2015

In a Federal Register notice published Wednesday, the FDA ordered drugmakers to stop making and distributing prescription ear drops that have not been approved by the agency as a treatment for ear inflammation, infection and pain. The FDA has not assessed the quality, efficacy and safety of the products, which may include hydrocortisone, benzocaine, pramoxine, chloroxylenol, zinc acetate and antipyrine in various combinations as active ingredients. The order does not cover over-the-counter drugs marketed legally or prescriptions with FDA approval. Medscape (free registration) (07/01)


8. Rise in poisoning cases prompts FDA to consider restrictions on liquid nicotine

FDLI SmartBrief | Jul 01, 2015

The FDA is asking for comments and additional information about liquid nicotine after recent increases in emergency department and poison control center visits related to liquid nicotine poisoning. Additional data will help the agency decide whether to release a public warning about the risks of being exposed to the substance, which is commonly used in e-cigarettes, and whether to require tobacco companies to distribute some of their products in child-resistant packages. Reuters (06/30)


9. Drug, device makers paid providers nearly $6.5B last year

FDLI SmartBrief | Jul 02, 2015

Drug and device makers paid $6.49 billion in 2014 to 607,000 physicians and over 1,100 teaching hospitals, according to the latest CMS Open Payments report. Unethical relationships are inappropriate, the American Medical Association said, but the organization stressed that relationships between manufacturers and providers have potential to educate clinicians and improve patient care. Reuters (06/30) The Wall Street Journal (tiered subscription model) (06/30) Health Data Management (07/01)


10. Justice Department ends probe into Abiomed's marketing of heart pump

FDLI SmartBrief | Jun 30, 2015

An investigation into Abiomed's marketing of its Impella 2.5 heart pump has been concluded by the Department of Justice. The company said it cooperated fully with the investigation, which began in October 2012. "We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first," said CEO Michael Minogue. MassDevice.com (Boston) (06/29)




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