The US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications. Read more »

The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »

The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. Read more »

One of the US Food and Drug Administration’s most important jobs is to provide the public with clear information about drug safety. Representative Joe Barton’s (R-TX) recent letter to the US Government Accountability Office (GAO) raises questions about whether FDA is telling us everything it knows. Read more »

The 2008 PDA/FDA conference opened this morning in Washington, DC, with keynote speaker and CDER’s top dog, Janet Woodcock. The theme of the plenary, “globalization through regulatory harmonization” is a must in today’s pharmaceutical industry.

“Heparin was a wakeup call,” demonstrating that we “need vigilance throughout the supply chain,” she explained. Woodcock added that solving these issues is “going to take a lot of harmonization” given the challenges present. Read more »

Many times innovation thrives in the wake of predicament. Earlier this year, the heparin-contamination issue sorely damaged consumers’ already delicate trust in the pharmaceutical industry but opened opportunities for several researchers to advance safer alternatives. Last week, at least two groups announced promising results toward this objective. Read more »

A second information request by Sen. Sherrod Brown (D-OH) of the Senate Committee on Health, Education, Labor and Pensions (HELP) on the outsourcing practices of a major pharmaceutical company—this time Merck & Co.—is moving the issue of outsourcing into an uncomfortable zone of political expediency versus constructive debate. 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 »

Sometimes you don’t realize how important something is until there’s a problem. Outsourcing is nothing new for the pharmaceutical industry, and many companies have come to rely on it. It helps companies stay lean and contributes toward profits.

Outsourcing is not a trouble-free strategy, however, as the contaminated heparin scandal attests. I can’t help but think that it was a careless attitude toward safety and quality standards that led to the problems. There is plenty of blame to go around. The drug company, the ingredient supplier, and regulators seem to have been asleep at the switch, and the results were both awful and avoidable.

This incident underscores what we already know: we need regulators to inspect ingredient suppliers and drug manufacturers to ensure that our medicines are safe and effective.

The problem is that sometimes we forget what we know. Read more »

Still think producing raw material overseas will reduce costs?

Earlier this week, FDA officials told Congress it needed $225 million in additional funding to inspect the 3300 foreign drug manufacturing facilities as frequently as it inspects facilities in the United States. This amount is nearly 20 times the agency’s existing budget for such inspections and about one-tenth its overall budget. Read more »