Legal News

In the prescription drug market, discriminatory pricing is common for independent community pharmacies and their patients. This fall, a Federal District Court in New York will consider a critical case: Drug Mart Pharmacy Corp. et a. v. American Home Products Corp. et al. The outcome of the case may determine whether discriminatory pricing techniques are illegal.

With the subject of healthcare reform on the front burner in Washington and across the country, Drug Topics invited members of its Frontline editorial advisory board to share their thoughts. A selection of their responses is presented here.

Hospitals and health systems have taken the lead in expanding the role of pharmacy technicians. "The better educated techs are, the more they can support pharmacists," says Mary Mohr, RPh, MS, of Clarian Health.

The FDA can require risk evaluation and mitigation strategies for certain prescription drugs and biological products, to ensure that the benefits of such products outweigh the risks. The effect of REMS ripples down through the supply chain to affect how pharmacies dispense medication.

When manufacture of biogenerics is a legal reality, brand manufacturers will still retain a strong market share for several years.

The FDA has announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies.

Pharmacy groups have filed three lawsuits that argue that California, New York, and Washington have not met their legal requirements to assure Medicaid patients receive access and quality care at least equal to patients in the general public.

Controversy is in the mix after two mail-order prescription surveys with conflicting results were released within two days of each other.

A coalition of healthcare industry groups has sent a letter to the bipartisan leadership in Congress seeking to delay pending Medicaid cuts.

The Joint Commission is targeting patient safety failures with a new program that will directly affect pharmacy operations.

GlaxoSmithKline has announced that the FDA's Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, the company's candidate cervical cancer vaccine.

Manufacturers, promoters, and sellers of dietary supplements are prohibited by law from making claims to treat or cure illness or disease, or their symptoms. Pharmacists should encourage patients to check with medical professionals before commencing use of any dietary supplement.

With the settlement of the class-action lawsuit brought against First DataBank and McKesson by third-party payors accusing the companies of conspiring to inflate average wholesale prices (AWP) of hundreds of drugs, AWP values will roll back from 1.25 to 1.20 times the drugs' wholesale acquisition cost (WAC).

The Iowa Board of Pharmacy is now one step closer to making its recommendation to the state?s legislature regarding the use of medical marijuana in the state.

The West Virginia Attorney General's Office has filed a lawsuit alleging that CVS Pharmacy, Kmart, Kroger, Walgreen Pharmacy, and Target violated a state law designed to promote use of generic equivalents for brand-name prescription drugs, according to media reports in the state.

In what it describes as an effort to stabilize and possibly decrease costs, a significant portion of which are associated with enforcement of laws and regulations, the Virginia Board of Pharmacy is testing new processes to help increase the efficiency of certain noncompliance issues.

The National Association of Boards of Pharmacy will convene a two-day task force Oct. 28 and October 29 to research various prescription-drug monitoring programs and recommend standards or model rules.

GlaxoSmithKline has announced that two lots of Advair Diskus medication were stolen earlier this month from the company's distribution facility near Richmond, Virginia.

The program created to provide Medicare recipients with prescription drug benefits exceeded expectations during its first two years. Keep reading to learn the details.

Keep reading to learn about some legal roadblocks in the way of pharmacy technicians.

The Pharmacists Society of the State of New York is fighting mad over the state's plan to contract with mail-order pharmacies to deliver high-cost medications to Medicaid customers.

The U.S. Food and Drug Administration has approved Saphris tablets to treat adults with schizophrenia, and bipolar I disorder in adults.

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 National Association of Chain Drug Stores and the National Community Pharmacists Association are moving ahead with their lawsuit against Delaware's changes to Medicaid reimbursement rates, even after Walgreen Co. said it no longer supports the suit.

A Miami resident has been convicted of both conspiring to divert human growth hormones and causing the diversion of these human growth hormones in interstate commerce.

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.

Over the next several years, generic versions of many best-selling drugs will become available as patents reach their expiration dates.

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 FTC has extended to November the compliance deadline for its "Red Flag" identity theft regulation, affecting all businessess that extend credit to customers.