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New electronic submission requirements imposed on
drug companies by the US Food and Drug
Administration (FDA) and its counterparts in other
countries are an example of how the government can
change the competitive landscape for information
companies. Twenty years ago, the Securities and
Exchange Commission (SEC) began requiring public
companies to submit their regulatory filings
electronically via the EDGAR system. The result was
a dramatic improvement in access and a quantum
increase in the size of the market, although these
came at the expense of some companies that had
built strong businesses compiling such documents.
In a similar move, the FDA has now begun requiring
pharmaceutical companies to submit labeling
information for each of their prescription drugs
electronically, using an XML-based standard. These
submissions include the package inserts, which
contain a rich set of reference information regarding
effective uses, clinical trials, adverse effects, and
dosing. Next year, the rules will begin extending to
over-the-counter drugs, medical devices,
diagnostics, and veterinary medicines. Similar
electronic filing requirements for new drug
applications are scheduled to be phased in over the
next few years. The FDA’s counterparts in other
countries also are in the process of instituting similar
electronic submission requirements.
While the FDA’s immediate concern is to facilitate its
job of reviewing submissions, the agency also plans
to put such information online for the good of the
public. Whether such moves serve to benefit
commercial publishers is yet to be seen. History
suggests that providing such fundamental information
in a standard electronic format will increase
competition among publishers and push them to
focus on enhancing the underlying information
through indexing, normalization, cross-linking, adding
related information, and integrating value-added
applications.
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