Why pharma might not want speedier drug approvals

KEY TAKEAWAY: The new head of the FDA is promising faster approval of prescription drugs, but without insurer buy-in and in depth clinical trials they could be lighting a giant “warning sign”.

In theory drug companies should love faster drug approvals by the FDA, but some drug companies say that it could also be walking into quicksand.  Insurers, who wield more power, like to have clinical information that new drugs provide better patient outcomes than current drugs, especially generics.

Then there is the issue of drug safety.  Drugs that are quickly approved could be a huge opportunity for the legal profession who loves class action litigation against drugs that, when used in a larger patient population, have more side effects  than are on the label.  If any doubt about that just Google Pradaxa and look at all the ads for lawyers suing the manufacturer.

Drug companies, the smart ones that is, should be conducting head to head clinical trials with drugs in development against the current standard(s).  Receiving FDA approval of a new drug only to have an insurer or insurers say “show me” could result in the loss of millions of dollars in sales and wasted marketing as patients and HCP’s are reluctant to try new products that have a higher co-pay.

One area the FDA really needs to address is the use of social media for DTC marketing.  Should drug companies, for example, be allowed to talk about the benefits of a therapy on Twitter without having to require fair balance?  Should the “one-click” rule for fair balance be an FDA standard and should fair balance be removed from TV spots?

It’s hard to play chess when the chess board is consistently moving, but this is healthcare marketing today.