A Good Question

A reader asks: "What of Congressional/presidential action that would prevent minor [or major] generic drug price increases."  I have waited a few days before responding because I think this serious question deserves thought, rather than a glib answer.

Some of my readers may have read Ezekiel J. Emanuel's "Opinion"article in the Sunday Review section of August 7, 2011's New York Times which touches on some of the issues related to a shortage of generic drugs effective against some cancers.  If you haven't read it, you should for it illustrates some of the complexities in this troubling area. [Some of my readers may recall my discussion of the Thursday lunch discussions at which oncologists described their difficulties in obtaining chemotherapy drugs to give their patients, which they ascribed to their purchasing drugs which patients were unable to pay them for, inability to get authorization from some insurers to pay for the drugs (or insurer authorization presenting expensive time-consuming bureaucratic hurdles to authorization), or difficulties accessing the drugs or being paid for their time, energy and staff whose burned up financial resources in the process.]  Several of my oncologist colleagues, who were superb physicians, have retired from their practices because (as they expressed it) of dissatisfaction with their ability to properly treat patients under the existing health care practice conditions  and because they were operating their practices at a financial loss.)

I have discussed some of the issues concerning the scarcity of generics, and their rising prices (inadequately offset for Medicare Part D  patients by price increases for generics which offset any savings the government may have garnered for them  when they reach the doughnut hole (i.e., 7%).  Congress and the President have the capacity to use governmental tools to answer significant questions and take action based on their findings: 1) has there been significant consolidation among generic drug producers (including those offshore) which reduces competition in the industry to the detriment of patients?  2) have large pharmaceutical companies acquired generic drug producers, or entered into joint operating agreements with them, which effectively reduces competition to the detriment of patients? 3) is the federal trade commission carrying out its intended function of promoting competition, or has it been sidelined to protect drug manufacturers from competition? 4) is the legal strategy of certain large pharmaceutical companies inhibiting the appearance of generic versions of their "branded" drugs when they go "off-patent"? 5) is the generic drug approval process inhibiting adequate public access to generics in reasonable quantities and at appropriate prices? 6) does the public have adequate information about the sources (country of origin, capability of the manufacturer, and quality of drug) of generics currently being sold in the United States and is that information based on appropriate investigation of those companies by an FDA which is adequately funded by Congress to carry out those functions? 7) Is the Orphan Drug Law being subverted through the introduction of a drug as a treatment for a rare serious disease and then the application of that drug to other treatments at a protected artificially high price? 8) is there financial transparency throughout the entire drug pharmaceutical production and distribution process or are there numerous unknown intermediaries who jack up the price of drugs without tendering services of commensurate value? 8) is our patent law artificially creating shortages of life saving generic drugs? 9) is the rebate, discount and kickback system applied by pharmaceutical insurers, the government and other actors in this field destructive of consumer protection?  10) and finally, does anyone with political power and authority really give a damn?