FDA May Ease Prescription-Drug Rules
Lawyer Blogs
The Food and Drug Administration may establish a "behind the counter" system allowing more drugs that currently require a prescription to be sold without one.
In a notice set to be published in today's Federal Register, the agency announced a Nov. 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."
Such intervention could require a pharmacist to make sure a patient meets certain criteria to get a particular drug and to instruct the patient how to properly use it.
Currently, most drugs are sold either with a prescription or over the counter in retail stores and pharmacies. The agency has carved out a few exceptions, including limiting distribution of Barr Pharmaceuticals Inc. "Plan B" emergency-contraceptive pill to pharmacies that agreed to keep it behind the counter and to require women to show a photo identification to prove they are age 18 or older.
Some groups that have called for a behind-the-counter status for drugs have said it might allow certain drugs sold with a prescription to be safely sold without one.
In 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
Along with a Nov. 14 meeting to solicit public comments on the issue, the FDA said it is also seeking written or electronic comments on the issue until Nov. 28.
The agency said it wants input such issues as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.
The agency said certain logistical questions would need to be addressed, including pharmacy storage and dispensing of the medications along with questions about whether and how pharmacists might be reimbursed.
Related listings
-
Texas Court Halts Inmate's Execution
Lawyer Blogs 10/03/2007[##_1L|1079899481.jpg|width="120" height="101" alt=""|_##]The Texas Court of Criminal Appeals brought the state in line with the effect of a U.S. Supreme Court review of lethal injection procedures by stopping Wednesday's scheduled execution of a Hon...
-
NYC Lawyer Guilty of Sex With Minors
Lawyer Blogs 10/03/2007[##_1L|1192727688.jpg|width="120" height="88" alt=""|_##]A tax lawyer accused of paying a woman so he could have sex with her two underage daughters pleaded guilty Tuesday to charges of statutory rape and patronizing a prostitute. James Colliton, mar...
-
Class Action Launched Against Harman
Lawyer Blogs 10/03/2007[##_1L|1289636783.jpg|width="120" height="138" alt=""|_##]Notice is hereby given that a class action has been commenced on behalf of an investor in the United States District Court for the District of Columbia on behalf of its client and on behalf of...

Victorville CA DUI defense Attorneys
The outcome of a DUI defense will have a long-term effect on anyone’s life, making the decision to receive legal representation an easy one. The fact is, most people accused of a DUI are first offenders with no criminal background. Whether this is your first run in with the law or you have had previous convictions, you are in need of a DUI defense attorney.
The charges you are facing for a DUI range from fines, a 12-month suspension on your license and worst-case scenario, prison time. Your attorney will be able to analyze your situation to decide the best way to go about your case.
Our attorneys know the tricky ways to challenge all of the DUI tests and know how to claim improper collection of evidence. We will be able to negotiate on your behalf and free you from charges and help you keep your drivers license. The DUI process can last up to several months, we can make this process easier on you. .