Do you remember the drugs Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Raxar and Redux? Pharma hopes not. How about Mylotarg, Lotronex, Propulsid, phenylpropanolamine (PPA), Prexige, phenacetin, Oraflex, Omniflox, Posicor, Serzone and Duract? After deaths and serious side effects surfaced, these meds went from wonder drugs to wonder-why-they-were-approved drugs and were withdrawn.

In some cases, there is little evidence the drugs were ever used or widely marketed or that anyone was injured. In certain cases, the withdrawn drugs were on the market for less than a year before things went “terribly wrong.” In other cases, the drugs were in wide use for decades despite well-recognized risks and pleas from public health figures to pull them. In almost all cases, Pharma companies maintained the drugs were safe and stuck to their story for as long as they could—not just to protect the company image and stock price but also to avoid adding fuel to injury lawsuits. (“The drug was so unsafe it was pulled” does not look great in court.)

When it comes to drug approvals, there is a basic tension between Pharma and regulators. The quicker a drug is approved, the more dangerous a drug potentially is but also the more quickly Pharma makes money. Since passage of the 1992 Prescription Drug User Fee Act (PDUFA), which lets Pharma pay the cash-strapped and underfunded FDA to “expedite” drug approvals, the scales have tipped toward Pharma and the time to get a new drug to market has decreased. While Pharma and the FDA have always been too collegial (and, with 23 industry links, the new FDA Commissioner Robert Califf essentially works for [3] Pharma), PDUFA allowed drug companies to pay for approval and for safety to be “bought.” It should be noted that drugs expedited under PDUFA are not intended for serious and fatal conditions—separate FDA programs [4] cover those.

Read More