FDA continues scrutiny of DTC genetic tests
September 15th 2010Underlying a recent FDA-hosted public meeting and workshop was the question of how FDA as a regulatory agency should increase its current oversight of clinical laboratories, specifically those developing genetic tests that may be offered at their own facilities or made available through direct-to-consumer channels.
Monitoring controlled substances
September 15th 2010Thirty-nine states now have a tool to help pharmacists identify at least some questionable prescriptions and suggest when a patient may be doctor-shopping or pharmacy-shopping in order to obtain controlled substances. That tool is the state prescription monitoring program.
FDA panel rejects REMS proposal for long-acting opioids
September 15th 2010FDA advisory committee members voted 25 to 10 to reject a proposed plan to establish a risk evaluation and mitigation strategy for extended-release and long-acting opioid analgesics during the joint meeting on July 23 of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in Adelphi, Md.
CER: Separating fact from fiction
August 15th 2010The 2,400-page healthcare reform bill included language establishing the Patient Centered Outcomes Research Institute, a group grounded in the tenets of comparative effectiveness research. Its mission is significant, but whether it has the power to effect change remains to be seen.
PPACA creates approval pathway for follow-on biologics
August 15th 2010Although the Patient Protection and Affordable Care Act (PPACA) creates an abbreviated approval pathway for biological products that are demonstrated to be ?highly similar? (biosimilar) to or ?interchangeable? with an FDA-approved biological product, only time will tell how long it will take for these biosimilars to reach the marketplace.
MTM bill seeks to help seniors manage medications, reduce healthcare costs
July 15th 2010Sens. Kay R. Hagan (D-N.C.) and Al Franken (D-Minn.) have introduced The Medication Therapy Management (MTM) Expanded Benefits Act, a bill that will allow seniors with one chronic illness to thoroughly review all their medications with a pharmacist in a one-on-one session.
Methamphetamine: Prescription-only or e-tracking systems?
June 15th 2010Oregon's law requiring prescriptions for pseudoephedrine products practically eliminated its illicit methamphetamine problem. But some pharmacists, consumer groups, and the drug industry say that it will increase healthcare costs and inconvenience consumers. They think electronic sales-tracking systems would be a better approach.
CVS faces probes by FTC, HHS, DEA; CEO Ryan to retire
June 15th 2010Both the FTC?s consumer protection and competition bureaus are spearheading an investigation into CVS Caremark?s alleged monopolistic practices. HHS is investigating possible false Medicare claims. DEA is investigating charges of improper sale of pseudoephedrine in 2007 and 2008. And the SEC has received complaints of insider trading.
Medical marijuana movement forges ahead
March 15th 2010While the government deems that marijuana has a "high potential for abuse" and "has no currently accepted medical use," some states have undertaken initiatives to pass legislation permitting its use for pain control and for control of nausea and vomiting by cancer patients.
RPh second victim in Ohio drug error
January 15th 2010A webinar examining the pharmacy error that led to the death of a two-year-old girl and the conviction of an Ohio pharmacist criticized the legal system for criminalizing the event as well as the flawed hospital procedures that prevented discovery of the pharmacy tech's fatal error.