Company websites, news websites, other content-based websites, and microblogging sites such as Twitter, are important vehicles of communication for disseminating information. A challenge for stakeholders in the pharmaceutical industry—the public at large, patients, medical personnel, drug companies, and regulators—is to have a mechanism for how that information can be effectively and responsibly communicated. Read more »

We all depend on the US Food and Drug Administration to enforce standards that keep our drugs safe. We expect the agency to set clear guidelines for consumers and manufacturers to follow. We also assume that the agency has standards for its own activities and ways of ensuring that agents comply with those standards. Unfortunately, a recent report from the US Government Accountability Office (GAO) shows that FDA has not entirely lived up to our expectations. Read more »

When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually be dangerous. Recently, the public and policymakers have become more aware of the issue of counterfeit medicines — especially as patients increasingly learn about how to shop safely online for pharmaceuticals. But scant attention has been paid to a safety issue that is also important to patients — the problem of substandard medicines. Read more »

Although the healthcare debate has dominated the news headlines as of late, an equally important consideration for the pharmaceutical industry is the effort by Congress to pass legislation on patent reform. Congress may be moving closing to that goal. On Feb. 25, Sen. Patrick Leahy (D-VT), chairman of the Senate Judiciary Committee, issued a statement that lawmakers have reached a tentative agreement on reforming the country’s patent system. Read more »

The Pharmaceutical Research and Manufacturers of America’s (PhRMA) announcement earlier this month that current President and CEO Billy Tauzin will step down at the end of June has raised the question of who will lead the association representing the innovator-drug industry. PhRMA says that it has already begun a search, so what are some of the key issues that the association should consider in finding a new chief policy advocate? Read more »

Attention has frequently been drawn to the complexities of getting anything done in Europe. A brilliant researcher can explore visionary horizons, an ambitious entrepreneur can offer a package of goods or services of inestimable value, but the degree of control and regulation becomes more intense every year — sometimes every month or week. Read more »

The health reform proposal unveiled by the White House on Feb. 22, 2010 retains a number of provisions that directly affect drug coverage and industry revenues. The plan highlights that it will close the Medicare drug benefit “doughnut hole” by 2020 to make drugs more affordable to the elderly. Seniors will get some relief this year through a $250 rebate, and coinsurance will phase down over the next decade. Read more »

There has been a surge in the number of combination product (i.e. where a drug product is combined with a medical device) launches in recent years and this trend is set to continue as more companies seek to extend the life of existing branded medicines. According to analysts, the combination product market is currently worth 8 billion Euros and will grow by a staggering 40% during the next 3 years. Read more »

The economic recession—recovering or not—was bound to affect FDA at some point. In his 2010 State of the Union address, President Obama proposed a spending freeze for US government agencies and programs that are not tied to national security. Entitlement programs such as Social Security and Medicare also would not be affected. “Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don’t,” said the President in his speech. Read more »

The numbers are in, and it looks like 2009 produced a bumper crop of biopharmaceuticals. The US Food and Drug Administration approved a record 16 new biopharmaceutical entities last year, as opposed to 10 in 2008, according to a study by the Biotechnology Information Institute. Seven recombinant-protein or antibody products were approved last year, continuing an upward trend for these molecules. Great news, right? Read more »