389 



However, there were many other questions that were more or less 

 relevant to the question of drug safety : 



1. Should the law require the physician to obtain a patient's consent before 

 prescribing an experimental drug for him? Was this indeed feasible? 



2. Should testing on animals be mandatory before experimental drugs are used 

 on humans? 



3. Should drugs be required by law to be identified and prescribed on a generic 

 rather than on a brand name basis? 



4. Should those conducting experimental testing or use of new drugs be for- 

 mally qualified? 



5. Should there be an approved "plan of investigation" of a new drug, before 

 the testing phase was permitted to begin? 



6. Should test reports, in writing, be made mandatory for all investigators of 

 new drugs? 



7. Should Government control be exercised over the selection of generic names 

 for drugs? 



8. Should drug investigators be required to register for each investigative 

 assignment they accepted? 



9. Should each individual investigator testing a new drug be required to report 

 his results directly to a Government agency, like the FDA? 



10. Should the review period before FDA approval of a new. drug be lengthened 

 substantially beyond the 60 days? 



11. Should the Federal laws regarding medical and drug practice be clarified 

 and doctors better informed as to what the law required? 



12. Should drugs be tested for efiicacy and safety, taken together, rather than 

 tested for safety alone? (I.e., should drugs intended for au extremely serious 

 disease or condition affecting a small portion of the population be accepted after 

 less extensive testing than that required for a drug to treat a minor disease or con- 

 dition affecting a large portion of the population?) 



13. Should FDA have authority to compel a drug to be withdrawn from dis- 

 tribution or inventory, on grounds that it is found unsafe subsequent to having 

 been approved for distribution by FDA? 



14. Should FDA personnel have full access to premises and records of drug 

 manufacturers, including their test data? 



15. Should FDA (or some other agency of Government) have an approval 

 function of drug advertising as well as drug labeling? 



16. Should all previously FDA-approved drugs be reviewed anew, under some 

 changed criteria, such as safety/efficacy? (I.e., should the safety/efiicacy require- 

 ment be made retroactive, and if so, how?) 



IT. Should a formal (national, or even international) system of detection and 

 communication be established to shorten the time of response to a drug-connected 

 (or perhaps more broadly, general medical) threatened disaster? 



Confronted by so many medical issues, and also the suggestive evi- 

 dence of high drug prices, the Congress was given an unreasonably 

 difficult task of sorting and evaluation. There was the practical diffi- 

 culty of winnowing fact from more than 15,000 pages of testimony 

 and exhibits — plus much additional interpretation and supplementary 

 material appearing in the Congi'essional Record, the press, and in the 

 releases supplied by interested parties. There was the intellectual dif- 

 ficulty that on some aspects and issues the medical profession v/as not 

 in agreement withiji itself — for example: 



As to the extent of reliance by practicing physicians on drug promotional 

 literature. 



As to the need for pharmacopoeia! versatility versus maximum reliability 

 through long experience with a lesser range of different drugs. 



As to the proper combination of formal scientific testing and repeated em- 

 pirical findings of general practice. 



As to the clinical equivalence of generic drugs from different sources and 

 brands, with differing marketing configurations. 



Unmistakable throughout all the deliberations after July 15, how- 

 ever, was the persistent recognition that prescription drugs would 



