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 »

A recent Wall Street Journal blog post, “The Problem with Drug Provenance,” broached an interesting debate on whether the origin of ingredients in a drug should be listed as part of the drug’s product information. Read more »

We all understand the benefits of quality by design (QbD), don’t we? Maybe not. Justin O. Neway of Aegis Analytical made me reconsider my assumption that this was true. During his presentation about achieving manufacturing-process excellence, Neway cited a survey that asked manufacturers what the biggest obstacle was to progress on their QbD programs. The most common response (given by nearly half of respondents) was that they had too many other things to do.

Come again? Read more »

As a law in my state, drivers are not “allowed” to pump their own gas. I suppose it has helped the Oregon economy with providing additional (read: low wage) jobs. In turn, our gas taxes may be a little higher than the rest of the country’s. Last week, however, as I pulled up to take another hit to the family budget with another fill-up, I noticed a sign at the station declaring “diesel customers: you are responsible for making sure the right gas is pumped into your vehicle.” Read more »