Box 48 History Of Regulation Governing Drugs And Biologics Marketed In The United States

• Food and Drug Act (1906). This first drug law required only that drugs meet standards of strength and purity. The burden of proof was on FDA to show that a drug's labeling was false and fraudulent before it could be taken off the market.

• Federal Food, Drug and Cosmetic Act (1938). A bill was introduced in the Senate in 1933 to completely revise the 1906 drug law—widely recognized as being obsolete. But congressional action stalled. It took a tragedy in which 107 people died from a poisonous ingredient in "Elixir Sulfanilamide" to promote passage of revised legislation that, for the first time, required a manufacturer to prove the safety of a drug before it could be marketed.

• Durham-Humphrey Amendment (1951). Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should be used only under a doctor's supervision.

• Kefauver-Harris Drug Amendments (1962). News reports about the role of an FDA medical officer in keeping the drug thalidomide off the US market aroused public interest in drug regulation. Thalidomide had been associated with the birth of thousands of malformed babies in Western Europe. In October 1962 Congress passed these amendments to tighten control over drugs. Before marketing, a drug company now had to prove not only safety but also effectiveness for the product's intended use. In addition firms were required to send adverse reaction reports to the FDA, and drug advertising in medical journals was required to provide complete information to doctors—the risks, as well as the benefits. The amendments also required that informed consent be obtained from subjects in clinical trials. (Note: In July 1998, thalidomide was approved by the FDA for an entirely different indication, with significant restrictions. Because of thalidomide's potential to cause birth defects, FDA invoked unprecedented regulatory authority to tightly control the marketing of the product in the United States.)

• Orphan Drug Act (1983). "Orphans drugs" are drugs and other medical products for treating rare diseases. They may offer limited potential profit to the manufacturer but may benefit people with these diseases. To foster development, this law allows drug companies to take tax deductions for about three-quarters of the cost of their clinical studies.

• Drug Price Competition and Patient Term Restoration Act (1984). This law expands the number of drugs suitable for an abbreviated new drug application (ANDA). ANDAs make it less costly and time-consuming for generic drugs to reach the market. Patient Term Restoration refers to the 17 years of legal protection given a firm for each drug patent. Some of that time allowance is used while the drug goes through the approval process.

• Generic Drug Enforcement Act (1992). This law imposes debarment and other remedies for criminal convictions based on activities relating to the approval of ANDAs.

• Prescription Drug User Fee Act (PDUFA) (1992). In this law, manufacturers agreed to pay user fees for certain new drug applications and supplements, an annual establishment fee, and annual product fees. Using these funds, FDA can hire

(Continued on next page)

0 0

Post a comment