US drug regulator faces Trump heat

FAILED REPUBLICAN presidential candidate Vivek Ramaswamy is making more news now than during his doomed attempt to get the party nomination for president. Ramaswamy's decision to throw in the towel and back Donald Trump after his campaign went nowhere showed acumen, the kind he is famous for in the investment world.

The president-elect has appointed the Indianorigin pharma investor, along with Elon Musk, as the head of an initiative to slash the federal bureaucracy. For Ramaswamy, heading the Department of Government Efficiency (DOGE) is the perfect reward: he does not like federal agencies and wants to shut down the Department of Education and the Federal Bureau of Investigation, and drastically restructure the Federal Reserve. But his main target is the Food and Drug Administration (FDA), the federal pharmaceutical regulator which has been in his cross hairs since the time he set up his drug manufacturing company Roivant Sciences and its much hyped drug failed to make the cut.

The story of Ramaswamy and his visceral antipathy to FDA is tied up with his business approach to pharma manufacture. He is given to projecting himself as a scientist from the biotechnology sphere, although he is no scientist, and has just an undergraduate degree in biology.

His graduate degree is in law and he started his career with a hedge fund company where he specialised in biotech investments. That appears to have fuelled the idea of setting up his own pharma ventures. His model was simple: scour the patent web for drugs that had been abandoned by pharma majors, buy out the patents-these could be had for a song-and develop and bring them to market to make a killing. The model was very much that of Martin Shkreli's, which we wrote about five years ago (see 'Encouraging orphan drugs', Down To Earth, November 1-15, 2019).

Shkreli was also a hedge fund manager who co-founded drug companies Retrophin and Turing Pharmaceuticals and became notorious for his rapacious pricing of pyrimethamine, a drug to treat parasitic infections. Shkreli had bought the rights to the drug at a throwaway price and hiked its price by 5,000 per cent.