They may be well-meaning, but sometimes the EU’s decisions can have harmful effects, as is the case with its much criticized clinical trials directive. Read more »

Last week, Sens. Sherrod Brown (D-OH), Sam Brownback (R-KS), and Al Franken (D-MN) introduced legislation, the Creating Hope Act of 2010 (S 3697), to provide incentives for drug companies to develop treatments for rare and neglected pediatric diseases. The legislation hopes to build on a private–public model to encourage targeted development for rare diseases. Read more »

The welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

The past two weeks have seen dozens of third-party headlines speculating about sanofi aventis possibly making a move to acquire Genzyme. Officially, there has been no word with both companies remaining extremely cagey about any of the details. However, Reuters, Bloomberg and a few other sources claim to have squeezed out a few dribbles of information from “people familiar with the situation” and anonymous staff members. So let’s take a look at what may (or may not be) the current situation. Read more »

Lundbeck (Deerfield, IL) issued a voluntary recall of its anti-inflammatory drug NeoProfen (ibuprofen lysine) Injection last Friday because it contains visible particulates, according to a company press release. The recall will cause a temporary shortage of the drug because the company recalled both lots that are currently available to prescribers. Read more »

As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

In the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

Communicating the risks of pharmaceuticals has never been easy. Say too much and no-one wants to take your drug; say too little and politicians, competitors and soon, the entire social media, will fill in the gaps for you. Read more »

The US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision. Read more »

It’s been a few months since President Obama signed into law the Patient Protection and Affordable Care Act (H.R. 3590). The bill includes a provision to “address gaps in quality, efficiency, comparative effectiveness information, and health outcomes measures and data aggregation techniques.”

Last week, the Partnership to Improve Patient Care (PIPC), which includes a wide range of healthcare organizations working to support the government’s role in and awareness of CE research, held a forum about delivering patient-centered comparative effectiveness (CE) research. Senator Max Baucus (D-MT) was the forum’s keynote speaker.

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