Daniel Carpenter: evaluation

Transcript context

…If major pharmaceutical companies want to run drug trials in poor countries — often it’s Africa, but it could be Latin America, other parts of the world — outside of the scrutiny of US regulators, should we allow that? Should we encourage it? Should we stop it? I think it should be allowed, but I also think that the FDA or any other regulator — say it’s Britain’s regulator, which by the way, I don’t think is that laissez-faire compared to Europe. If anything, European pharmaceutical regulation — from which Britain has just only recently broken — has long been at least as procedurally conservative as the US, say, since the 1990s. I think it’s entirely fine for some of these wealthier countries to say, “Well, we don’t trust those trials and we’re not going to rely upon those trials alone” in, say, a pivotal phase III or a really important phase II trial. You get into problems with what’s the quality of a country’s institutions, and this is something we usually think about from the standpoint of, say, somebody like Robert Putnam or Douglass North or Margaret Levi, but I think institutions and the credibility of scientific institutions is also important. Back when I wrote the book on the FDA, I spent a little bit of time in India and thinking about its issues in regulating drugs. Of course, there’s a lot of drug manufacturing in India, a lot of generics manufacturing and so forth. I don’t know the stats offhand, but the FDA has any number of times had to crack down on generic drug manufacturers in India. There have been a whole host of quality problems there. If we think that a country has weak scientific and credibility-based institutions, then I’m fine with allowing the trials there, but I’m also fine with regulators in so-called advanced industrial countries saying, “Yeah, we’re not going to allow those trials. We’re not going to accept those trials as pivotal for approval.” Okay. We now get to your new book. Again, I’ll repeat the title, Democracy by Petition: Popular Politics in Transformation, 1790–1870. It helped me think about a whole host of issues anew. First question: how and why were petitions key to the women’s rights movement in the 19th century?…

Stored transcript either side of the excerpt. The highlighted words are the published quote; the surrounding text is unedited source, never generated.