Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

In a news release issued by the European Organisation for Rare Diseases (EURORDIS) this week, the society commended the European Medicines Agency (EMEA) in its efforts to make the information that it has available on medicines more patient-friendly. Read more »

The pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.

That’s why news from Ecuador made me do a doubletake. Read more »

This month, lawmakers such as Senator Kent Conrad (D-ND) and Senator Edward Kennedy (D-MA) have introduced a flurry of healthcare-reform bills that provide for comparative-effectiveness (CE) research. Supporters of CE research say that it could cut unnecessary costs by identifying the treatments that produce the best results. Federal and state governments’ share of the national healthcare bill could consequently be lighter, yet critics fear that promoting CE research could give the government too much power over treatment. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? 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 »

I like it when the government takes its responsibility to
protect us seriously. Last week, Senator Sherrod Brown (D-OH) started asking FDA to evaluate how pharmaceutical outsourcing affects public safety. Brown no doubt had the contaminated heparin story in mind when he asked CDER Director Janet Woodcock about the connection between outsourcing, contaminated ingredients, and countries with weak safety regimes. Read more »