Regulatory Beat: Changes and Challenges at FDA - Manufacturers will find some controversial initiatives delayed, while efforts continue to address product safety concerns - BioPharm International


Regulatory Beat: Changes and Challenges at FDA
Manufacturers will find some controversial initiatives delayed, while efforts continue to address product safety concerns

BioPharm International

The importance of addressing drug safety issues is apparent from a number of agency initiatives. FDA has scheduled a public meeting next month (December 7-8) to solicit public comment on its traditional means of communicating about drug risk, such as issuing talk papers, health advisories, press releases, and posting adverse event information from its MedWatch system. The agency's new Drug Safety Oversight Board has begun to privately assess safety concerns, while agency staffers evaluate comments on the proposal to make public emerging drug safety information on a new "Drug Watch" website.

These and other activities are part of a broad initiative to build a central electronic information system that can provide up-to-date information on medical product safety and appropriate use. Unofficially dubbed "Facts@FDA," the system ultimately will contain current product labeling information plus safety data gleaned from adverse event reports. Additional information on drug safety and outcomes also will come from Medicare and health plan information systems that collect extensive data on prescription drug prescribing and use; FDA signed a contract in September with four leading health plans to provide post-market surveillance data on 11 million covered patients.

A key component of Facts@FDA will be the DailyMed data bank of prescription drug labels, operated by the National Library of Medicine. Manufacturers began submitting changes to drug labels electronically this month (November 1, 2005) using the recently adopted Structured Product Labeling (SPL) standard. DailyMed also will obtain electronic drug labels as new drugs are approved and as manufacturers submit annual reports with revised labels to fit the new format.

Over the next year, DailyMed should obtain electronic information on all marketed prescription drugs, including generics and biotech therapies regulated by the Center for Drug Evaluation and Research (CDER). The system will make it easier to revise label information to fit the new format established by FDA's final professional labeling rule, which has been anticipated for many months. Ultimately, patients will be able to obtain current product labeling information via the Internet or from pharmacy kiosks, eliminating the outdated paper package inserts that are costly for manufacturers to produce and of little value to patients.

The future vision is for DailyMed label information to link to adverse event reports filed by manufacturers and FDA's MedWatch program. FDA currently makes this data available to the public on a quarterly basis, but Gottlieb suggests that more frequent Internet postings may be useful. FDA's hope is that making it easier for healthcare practitioners to access current drug adverse event information may encourage more physicians to report signs of trouble to MedWatch, something they now do very infrequently.

A third component of the envisioned Facts@FDA system may be reports of emerging drug safety signals from FDA's proposed DrugWatch website. Pharma companies and health experts worry that the public may become confused and overly alarmed by reports of drug safety problems that may be very preliminary — but appear as official FDA warnings. Whatever form the final system takes, more immediate access to information on a drug's side effects and appropriate use could address many post-approval drug safety concerns and affect how safety and efficacy information is collected in clinical trials.

Jill Wechsler is BioPharma International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

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