- State Board Stepping Up Pharmacy Inspections (specialtypharmacytimes.com)
Massachusetts Board of Registration in Pharmacy recently released its 2014 annual report on investigations and disciplinary actions against retail chain, independent community, and compounding pharmacies...regulators reported a "noticeable field presence" with an increase in investigative staff and greater interest in keeping tabs on sterile compounding pharmacies.
- Pharma plants strike in Pakistan protest QC rule changes (in-pharmatechnologist.com)
More than 100 plants in…Islamabad, and in…the Punjab province are downing tools in response to amendments by the regional government to the Drug Regulatory Authority of Pakistan Act,… proposed changes would do away with the Out of Specification production category, which is used by international regulators for batches that do not meet pharmacopeial specifications. Instead.. new rules would mark all failed products with the…term "Spurious", a classification that..encompasses unregistered and counterfeit medicines, and products containing no active pharmaceutical ingredient…
- FDA approves first treatment for sexual desire disorder (fda.gov)Approved Risk Evaluation and Mitigation Strategies (REMS) (accessdata.fda.gov)
Addyi is being approved with a risk evaluation and mitigation strategy, which includes elements to assure safe use…because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol…REMS requires that prescribers be certified… Additionally, pharmacies must be certified…Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber...
- State Accidentally Mails Out Private Health Information To The Wrong Patients (denver.cbslocal.com)
Protected health information from the (Colorado) Department of Health Care Policy and Financing was unintentionally mailed to the wrong people,… the letters were mailed between May 25 and July 5. A resident who received a letter not intended for that resident notified county workers about the error...
- Concordia, Par Pharmaceutical settle anti-competition charges -U.S. FTC (reuters.com)
Concordia Pharmaceuticals Inc and Par Pharmaceutical Inc have settled charges they unlawfully agreed not to compete in the sale of a generic version of Kapvay (clonidine), a drug used to treat attention deficit hyperactivity disorder,…Federal Trade Commission…alleged Concordia,…had agreed not to sell…drug in exchange for a share of Par's revenues…. settlement bars them from enforcing anticompetitive provisions of their agreement, including the profit-sharing provision..
- AbbVie buys special review voucher for $350 million (reuters.com)
AbbVie Inc has bought a (FDA) priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs…pediatric disease priority review voucher…eligible to have one of its drugs reviewed in six months, compared to the standard 10 months...AbbVie did not disclose its plans for the voucher...
- Pharmacy Students Participate in Mock Trial Based on Real Error (pharmacytimes.com)
Considering that a pharmacist’s mistake may cost a patient’s life, one class at Auburn University’s Harrison School of Pharmacy prepares pharmacy students for the gravity of their actions…. Foundations of Pharmacy course for incoming students has included a mock trial… Begin imagining yourselves in the chair as the defendant in the case, a pharmacist who has practiced for some time [and who] made an error….
- Amgen pays $71 mln to settle Enbrel, Aranesp marketing case (reuters.com)
Amgen Inc has reached a $71 million settlement ...to resolve claims that the biotechnology company promoted its popular Enbrel and Aranesp drugs for uses not approved by the federal Food and Drug Administration… Amgen violated state consumer protection laws by marketing both drugs for off-label uses, through its promotion of Enbrel to treat mild plaque psoriasis and Aranesp to treat anemia caused by cancer.
- Jailed Las Vegas doctor’s patients irked over cost to get medical records (reviewjournal.com)
Patients of a jailed Las Vegas doctor accused of drugging and sexually assaulting women in his care say they are being told they must pay excessive amounts of money to retrieve their own medical records….they have been told they must pay $20 for the paperwork kept in Dr. Binh Chung's office… may not be in line with Nevada law.
- F.D.A. Approves Addyi, a Libido Pill for Women (nytimes.com)FDA approves first treatment for sexual desire disorder (fda.gov)
first prescription drug to enhance women’s sexual drive won regulatory approval …victory for a lobbying campaign that had accused the Food and Drug Administration of gender bias for ignoring the sexual needs of women…Addyi (flibanserin) — is actually the first drug approved to treat a flagging or absent libido for either sex. Advocates who pressed for approval…Even the Score, said that a drug to improve women’s sex lives was long overdue… National Consumers League..the campaign behind Addyi … made a mockery of the system that regulates pharmaceuticals..