Jim Mullen, who also chairs the BIO trade group, is plain spoken this morning in an editorial in The Wall Street Journal. And he points a sharp finger at Congress for pushing a ‘witches’ brew’ of legislation that, naturally, he believes will hurt biotechs and, by extension, just about everyone else.

He sounds off on the hot topics of the day, but saves his strongest remarks for the biosimilar debate. Here are his points:

On Medicare: “Forcing our companies to negotiate directly with the federal government sends a clear signal to investors that prices will be dictated - not negotiated - by the agency that runs Medicare. We’ve seen price-control attempts before on biotechnology, and the results were not pretty. During the 1993-94 health-care reform debate, the biotech stock index fell approximately 40 percent. The retreat by investors was felt by large and small companies alike. Actually repealing Medicare’s non-interference clause could have similar results.”

On drug safety: “We are dealing with an irrational drug-safety scare…If the intent is to really improve drug safety, we should provide robust, steady funding for the FDA. Approximately 53 percent of the agency’s operating budget currently comes from drug company user fees. That is too high, and it fuels a perception problem for an agency that regulates 25 percent of the US economy - and almost everything Americans put into their bodies.”

On biosimilars: “In the rush to embrace all things that appear to drive down health-care costs, Congress should step back and move very thoughtfully on any legislation concerning generic versions of biotech drugs. More accurately termed “biosimilar” legislation, getting this wrong could result in reduced R&D spending, or possibly unsafe drugs being pushed through a scientifically-flawed regulatory process.

Could this happen? Yes, because unlike traditional pharmaceuticals, which typically come in pill form, biotech products are large protein-based therapies that are usually injected by patients…To be clear, when the science is ready, biosimilars should be approved in the US. But the science should be demonstrated through rigorous clinical trials to help ensure patient safety. In fact, the European approach may serve as a model. They have taken early and prudent steps to ensure that benefits, risks and incentives for innovation are weighed in the process. In short, they have constructed a framework predicated on sound medical science — not on political science.”

Who disagrees? Is Jim right about the amount of user fees to be paid the FDA? Does he strike an appropriate midground on biosimilars or is just self-serving rhetoric?

Full essay is available here (subscription required).[tags]Biogen Idec, Biologics, Generics[/tags]