The Other Drug War
The FDA still treats the 1962 law as a triumphant moment that “revolutionized drug development” because its scientific safeguards ensure “that consumers will not be the victims of unsafe and ineffective medications.” And therein lies the problem. The FDA celebrates the supposed advantages of Kefauver-Harris, but it ignores the major monkey wrench that it has introduced into drug development. Its proclamation looks at only the benefits of the drug-approval process, but wholly ignores its attendant costs by tacitly assuming that the only drugs that the FDA keeps off the market are unsafe and ineffective.
Regrettably, in this, as in all other regulatory endeavors, there are two kinds of error. The FDA is keen to note the bad drugs that are kept off the market. But it downplays the good drugs caught inside its web that are kept off the market. In some cases, there are deadly delays in getting good drugs onto the market.