Legal News

The U.S. Food and Drug Administration published two rules recently to help clarify how very ill patients can obtain access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and have no other satisfactory treatment options.

The death of a teenager led Congress to pass the Ryan Haight Online Pharmacy Consumer Protection Act in 2008, amending the Controlled Substances Act to prohibit delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription.

Pharmacy mistakes can sometimes lead to injury or even death. Pharmacists can be held liable in a civil suit for money damages; now a pharmacist in Ohio may be convicted of a criminal charge in the accidental death of a two-year-old girl. It is possible that the effect of criminal liability upon professional practices will worsen outcomes rather than improve them.

In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the generic or "follow-on" versions of biologics. Two bills before Congress approach the issues differently.

The National Community Pharmacists Association (NCPA) recently wrote to a key standards-setting body requesting action on a number of regarding a new Internal Revenue Service requirement meant to ensure flexible spending account debit cards are used properly that is seen by the association as problematic.

The National Community Pharmacists Association (NCPA) is still working to urge Congress to exempt community pharmacies from the Oct. 1 accreditation and surety bond requirements needed to continue providing durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) to Medicare patients.

Congress gave the Food and Drug Administration (FDA) jurisdiction over tobacco in June, but don?t look for any quick changes in tobacco policy, products, or marketing. The agency is asking the public for guidance before jumping into regulation.

More than 80 community pharmacists from the National Community Pharmacists Association (NCPA) and several patients met with the Federal Trade Commission (FTC) May 13 to discuss concerns about the impact of the March 2007 CVS/Caremark merger and to urge the FTC to re-examine it.

The major message of the 2009 National Community Pharmacists Association's Annual Conference on National Legislation & Government Affairs was "get into politics, or get out of pharmacy."

The New York Senate is considering a bill to permit qualifying seniors to obtain their prescription medications from a Canadian pharmacy group. New York pharmacists oppose any plan to take pharmacy dollars out of the state.

With violence against pharmacists mounting across the country, the National Institute for Occupational Safety and Health (NIOSH) initiates a long-range study.

Widespread confusion about the new label format for prescription drugs has sent FDA officials to association meetings around the country, explanations in hand.