The most difficult part of Steve Laffey’s campaign platform for the traditional Republican base to swallow (so to speak) has been his promise to “fight the big drug companies”. On Monday, Mayor Laffey laid out in detail his plan to remedy high drug costs. (Katherine Gregg and Jim Baron both provide good tastes of the overall flavor of the presentation in their reporting in the Projo and the Pawtucket Times, respectively).
Mayor Laffey summarizes his program in terms of six problems with six solutions. The first two problem/solution pairs are based on the assumption that pharmaceutical industry advertising creates an “artificial” demand that keeps drug prices high…

Today’s Problem: Direct-to-Consumer advertising can inflate the need for brand name drugs and lead to inappropriate prescribing.
Laffey’s Solution: Re-instate pre-1997 FDA disclosure requirements (for full-disclosure of ALL side effects).
Today’s Problem: Drug companies are spending more dollars on “Me-too” drugs that don’t improve America’s health.
Laffey’s Solution: Require new brand name drugs to be superior than current drugs (or no patent!)

Here are some general concerns about this set of solutions.
1. Certainly advertising is influential (after enough TV-ads, people will actually consider voting for Matt Brown for the Senate!) but prescription drugs, by being “prescription”, are already supposed to involve a layer of protection between advertiser and consumer. They can only be sold after being prescribed by a doctor. In theory, doctors’ judgements shouldn’t be swayed by slick advertising campaigns.
If there is a problem with advertiser created demand, doesn’t a large measure of the problem have to reside with the doctors who are writing the prescriptions? Also, if advertising is this powerful (and profitable), then why haven’t generic drug makers developed their own advertising campaigns announcing that their drugs are just as good as brand name drugs to increase the demand for generic products?
2. The focus on “me-too” drugs — drugs that have a different enough chemical composition to get their own patent, but serve the same function as a previous drug (the less perjorative term used to describe them is “follow-on” drugs) — raises some specific concerns. The argument against follow-ons is that they inflate drug prices by discouraging people from purchasing cheaper generic drugs after the latest-greatest brand names hit the market.
Not everyone, however, agrees that follow-ons, because they have the same function as their parents, are all bad. The first argument for follow-ons is that they are necessary for providing treatment to patients who cannot use the orginal due to allergies or side-effects. (John Calfee of the American Enterprise Institute makes this argument). The second argument is good, solid economics. In theory, follow-ons ultimately drive prices down by making negotiation with drug companies possible by increasing the supply of drug options available for treating a particular problem. Too much regulation against follow-ons would restrict supply of available treatments, ultimately driving prices up. (Malcom Gladwell argues this position in the October 25, 2004 issue of the New Yorker).
Have all of the possible consequences of increasing the regulatory burden on developing follow-on drugs been given their due diligence?
Up Next: Some very sensible suggestions in the Laffey Plan on FDA & Patent Reform…