The Competitive Status of the U.S. Pharmaceutical Industry The Influences of Technology in Determining International Industrial Competitive Advantage (1983) / Chapter Skim
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5. Options for American Industrial Policy
5. Options for American Industrial Policy
Pages 77-88
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From page 77... ...
On the other hand, if the United States is to maintain standards of living comparable to those of other major industrial nations, it cannot suffer indefinite economy-wide declines in its share of world markets. It is now almost 40 years after World War II and more than a decade after certain western European nations equalled the United States in per capita national product.
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From page 78... ...
This prohibition holds regardless of the comprehensive approval or not for marketing of a particular drug in the importing country by local regulatory authorities. This procedure provides an obvious incentive for firms of all nationalities to-produce drugs outside the United States, particularly in light of the fact that FDA regulation tends to entail longer than average approval delays.
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From page 79... ...
The restoration of patent time would simultaneously render investment in new drugs more attractive and expand the cash flow from which new drug research is needed. Patent restoration should be particularly important for 'breakthrough" or therapeutically significant new drugs as these novel compounds often take longer than average for regulatory approval and hence currently receive an even shorter than average patent life.
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From page 80... ...
Treasury regulations recently issued to implement Sec 1.8 61-8 of the Internal Revenue Code require that R6c D expenditures b e apportioned to both foreign source and domestic income in an effort to recognize the fact that innovations in the United States often result in licensing and other revenue from foreign sources. However the effects of the regulations are (1 )
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From page 81... ...
Because of th e enormous public pressure on FDA to be certain about its decisions, the agency requires a substantial amount of preclinical and clinical testing, closely scrutinizes new drug applications, and consumes substantial periods of time in the regulatory process. Since 1955, it has been recognized that the new drug approval process needs revision.
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From page 82... ...
Thirteen of the more important Commission recommendations, and comments on the improvement they could make in pharmaceutical technology, follow. The IND Process Early Clinical Research To permit more drugs to be tested more expeditiously, the preliminary requirements for introducing new chemical entities into humans (such as drug chemistry, animal toxicology, and protocol specificity)
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From page 83... ...
Use of expert panels outside FDA to review IND submissions for clinical pharmacology research would encourage such research by reducing the regulatory burden and cost. The NDA Process Application of the Standards for Drug Approval The FDA Commissioner should clarify through regulation the interpretation and application of the statutory and regulatory standards for establishing substantial evidence of the effectiveness of a new drug.
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From page 84... ...
On the request of the FDA or the drug sponsor, outside expert consultants should be available both to advise in the investigational development of each new drug entity or important new use of an approved drug and to participate in the review of its NDA. As already noted, use of outside experts to resolve scientifi c policy issues will help assure better scientific decisions and expedite the entire NDA review process.
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From page 85... ...
Im proving Interactions with Industry The FDA Commissioner should encourage the timely and equitable resolution of disputes regarding INDs and NDAs by ensuring that mechanisms appropriate for different types of disputes are in place and readily accessible. In particular, the Commissioner should expand on existing mechanisms and explicitly encourage their use.
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From page 86... ...
Current restrictions unnecessarily limit the availability of many highly qualified experts whose advice could be important in the prompt resolution of important questions. Im proving Interactions with Industry The FDA should provide guidance to its staff to encourage all review personnel to conduct timely, forthright, and evem handed discussions with sponsors of the significant issues that arise at any time during the IND and NDA review process.
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From page 87... ...
No. HRD-80-64, 1980; Pracon, Inc., The Effective Patent Life of P harmaceutical Products: Trends and Im plications, 1978; and Eisman and Wardell, ''The Decline in Effective Patent Life of New Drugs," Research Management, January 1981.
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