Barely a month after its ruling in Bruesewitz v. Wyeth, the US Supreme Court has begun to hear arguments in another case with big ramifications for drugmakers. The current case raises questions about generic-drug companies’ responsibilities and whether federal law pre-empts state regulations, among other issues. Read more »

Healthcare-reform legislation is not the only federal initiative that is affecting pharmaceutical manufacturers these days. US Attorney General Eric Holder is cracking down on healthcare fraud, including false claims against Medicare and Medicaid. AstraZeneca (London) felt the sting of Holder’s campaign when it agreed last week to pay $520 million to resolve accusations that it marketed its atypical antipsychotic Seroquel illegally. Read more »

Patients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »

Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release. 

The agency has been actively involved in several recent cases involving instances of illegal importation and sales, drug diversion, and misbranding of drug products. Read more »

UnitedHealth Group, a Minneapolis-based healthcare company, recently announced that it would soon provide a price break to members who correctly use certain asthma and antidepressant drugs. The news was reported in a Wall Street Journal article by Peter Loftus of Dow Jones Newswires.  

To get the $20 copay discount, members must refill their prescriptions within about 30 days after their last prescription runs out. Eligible drugs include GlaxoSmithKline’s Advair, AstraZeneca’s Symbicort, Eli Lilly’s Cymbalta, Wyeth’s Effexor XR, and Wyeth’s Pristiq. The discount applies to members who have a normal copay of $50 on these drugs, meaning the new copay would be $30, according to Loftus’ article. Read more »

Congress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

Like a snowball that gets bigger and bigger as it hurtles down the side of a mountain, generic drugs pose an increasingly large threat to branded pharmaceutical companies. Wolters Kluwer Health’s annual analysis reveals that more than 60% of all US prescriptions filled in 2008 were generics. For orally administered medicines, the percentage was even greater. In 2008, 2.4 billion prescriptions were filled for generic drugs, and only 1.4 billion for branded therapies—an unprecedented divide, according to the report.

What’s Big Pharma to do? Read more »

Many state legislatures are looking for ways to keep their healthcare costs down. Given our difficult economy, attempts at fiscal prudence do not come as a surprise. What’s heartening is that many states’ bills draw a link between healthcare expenses and doctor–patient confidentiality. Read more »

Two new studies highlight the steps-some of them too risky-that patients are taking to protect their pockets from totally emptying.

One study from the Center for Studying Health System Change reports that one in seven children and working-age Americans went without a prescription drug in 2007 because of cost concerns. Read more »