"I Want A New Drug..."
Marjorie Lazoff, MD
Emergency Medicine
Philadelphia, Pennsylvania
Medical Editor
Medical Computing Today

accepted for publication in Medical Computing Today March 1999
Originally published in the February 1999 issue of Medical Software Reviews

FDA - References - News/Reviews - Post-marketing - Investigational

Somewhere in cyberspace is pre- and post-marketing information on the "new drug" pined for by Huey Lewis and the News. But like most new drug information on line, it won't be immediately available or very easy to locate. Worse, the information may be proindustry rather than objective or wholly scientific. But as several sites suggest, with greater professional attention the Web can become an authoritative, convenient, and timely medium for sharing clinical information about newly approved and investigational drugs, and new indications and findings on already familiar therapies. Of course, all these drugs are being sold on line today as well -- but that's for another NetView, and song.

Sections The FDA

The only portion of The US Food and Drug Administration (FDA) Web site that is not confusing is its home page. Otherwise, the site posts multiple overlapping lists of new and approved products, warnings, withdrawals, and other resources. The most current medical approvals and recalls, diluted with agency news, are maintained at FDA News Page. Recent listings are up-to-date and include, for example, recall of salted uneviscerated yellow croaker fish; a warning about products containing GBL and request for recall; and a press release describing FDA approval of Pletal (cilostazol).

The FDA Center for Drug Evaluation and Research's (CDER) New Drug Approvals is updated weekly but only provides drug names and manufacturers' information. Many sites link to this page, but direct access is recommended to insure the most recent postings. January 1999 listings include Pletal, Sonata (zaleplon), and Comton (entacaprone) along with dozens of labeling supplements. New and Generic Drug Approvals is a temporary page listing all new drugs, indications, and insert information since 1998. Drugs are listed alphabetically in tabular form, with links in PDF format. For the FDA's main menu of all new, current, and outdated drug databases, see Drug Information.

FDA's Center for Biologics Evaluation and Research (CBER) is better maintained. See CBER's What's New for a list of newly approved therapeutics such as Lyme Disease vaccine (recombinant OspA), anti-thymocyte globulin, abciximab, etanercept, and basiliximab. Also listed are month-old Recalls/Withdrawals/Safety Issues, primarily of blood products. More detailed information is available on Recent Federal Registry Notices, listed daily in chronological order over the past six months.

As part of the FDA's post-marketing reporting and surveillance program, MedWatch monitors and disseminates new safety information on medical products throughout the medical community. MedWatch's mission suits the Web perfectly, but continued site development is needed for the health care profession and pharmaceutical industry to really benefit. More than 140 medical specialty associations, health corporations, and government groups support the agency as MedWatch Partners; those looking to bookmark a list of links to various major medical organization Web sites will enjoy this page.

MedWatch's home page is inelegant but functional. From here users can access What's New the Past Two Weeks, such as the GBL warning, a current letter on Flovent, and one from six months earlier on Carnitor (levocarnitine). What's New is relative to the site, since it sometimes takes the FDA months to put new information on line. There's an e-mail list for those wishing to be notified whenever new material is posted.

Safety Announcements, MedWatch's main resource, is also accessed from the home page. It is divided into several sections, most notably "Dear Health Practitioner" Letters and other Safety Notifications (such as GBL and Flovent), and Labeling Changes (alas, two months late). Both are organized by year, the latter further divided into months, and each has a Quick Reference section. Scroll down this page for the weekly Enforcement Reports on its numerous food recalls. Safety Announcements is badly in need of a search engine, but once a product is located old references are linked to present announcements.

FDA's Center for Devices and Radiological Health's New Items also allows for e-mail notification of updates. Fans of Clinton's State of the Union address -- and those responsible for clinical, laboratory, or biomedical equipment or devices -- will appreciate the FDA's Federal Y2K Biomedical Equipment Clearinghouse Database. The government requests manufacturers provide information regarding the impact of the Year 2000 date bug on product performance; the procedure for reporting is described in detail. The database is searchable or can be browsed or downloaded.

The FDA's What's New on the HIV/AIDS Web Page is a well maintained reference for drugs and warning with any relation to these disorders.

Sections New Drug Reference Entries

Registrants have free, unlimited access to The Physicians Desk Reference via PDR.net. Kudos to Medical Economics for providing this generous database, although the online PDR is not the most updated version. Recent (a relative term) entries under PDR Addenda include Atacand (candesartan), Celexa (citalopram), Droxia (hydroxyurea), Integrilin (eptifibatide), Omnicef (cefdinir), Synagis (palivizumab), and Teczem (enalapril/diltiazem). Note too that the content is full of distracting, illogical definitions linked to Stedman's Medical Dictionary. For example, under Droxia (hydroxyurea), the sentence, "The physician and patient must very carefully consider the potential benefits of Droxia relative to the undefined risk of developing secondary malignancies," defines the words physician, patient, must (defined as "unfermented juice"), potential, and risk -- and not what is probably the sole deserving term, secondary malignancies. The site posts pharmaceutical ads, including banner ads for drugs that one has just searched.

RxList's What's New includes monthly additions to its 300 drug monographs. For example, January 1999 lists Fludara (fludarabine), Rituxan (rituximab), Betapace (sotalol), Herceptin (trastuzumab), Avapro (irbesartan), and Maxalt (rizatriptan), among others. The site accepts pharmaceutical ads, and here too searched medications came up shortly thereafter as banners. The site is credited to Neil Sandow, PharmD, and, while the old monographs come from the 1998 GenRx, the source of the new monographs is not stated.

Pharmaceutical Research and Manufacturers of America's (PhRMA) New Medicines in Development is divided into Approved Medicines, and Drugs In Development (in categories such as AIDS, African-Americans, and Biotechnology). These PDF-formatted reports are well organized, readable, and informative but many are dated by months to a year or more, and all carry a proindustry slant.

Centerwatch's Listing of Newly Approved Drug Therapies is organized by specialty and year. The sole listing under 1999 is Famvir, but prior years appear complete. Each drug is linked to a short nontechnical description. F-D-C Reports' Pharmaceuticals Approval Monthly briefly describes requests, clinical trials, and other information affecting FDA approvals. The database is behind by several months, and the full text articles are not freely available on line. The same company also shares news on Medical Devices.

Sections News and Reviews

POL's Rx Launch, freely accessible to POL registrants off its frames home page under Drug Information, is a thoughtful resource. Following a thumbnail description of each drug is a button to an intermediary page linking to prescribing information; preformatted PubMed, Yahoo Internet, and Reuter's Medical News searches; MediSpan's interactions database, and a discussion group. Drugs presently listed were approved in June-October 1998 (alas, nothing more current): Pulmicort (budesonide), Atacand, Celexa, Arava, Priftin (rifapentine), Thalomid (thalidomide), Maxalt, and Integrilin.

Doctor's Guide to New Drugs or Indications links to press releases in chronological order. This well-maintained resource is updated several times a week. For a daily fix, scroll halfway down Medscape's Pharmacotherapy Home Page for MedscapeWire, Medical Tribune, press releases, and other news sources.

For pharmaceutical-related press releases, and reports from Reuters and other mainstream news sources see Johns Hopkins -- Aetna/U.S. Healthcare's InteliHealth Professional Network Pharmaceutical, Science and Research, and Products and Technical. These articles are not available on its consumer site.

Twice monthly, Drug Topics' New Products Newswire lists summaries of new medications and indications. Hot Off the Presses occasionally includes information on new medications, but with a business/industry slant. Drug Topics is a biweekly journal for pharmacists.

Medical Sciences Bulletin, the major content resource for the popular PharmInfoNet site, now contributes a What's New page of medications for the pharmaceutical industry, with enough clinical information to be helpful to physicians and other health professionals as well. Drug PR is an alphabetized listing of manufacturer press releases updated monthly since 1998. The list is too extensive to be useful for scanning most recently approved drugs, but can be used to gather further information on a particular drug.

An article on FDA Updates comes from the January 21, 1999, issue of Medical Tribune; the home page of this biweekly newspaper contains short articles related to new medications and indications.

Scroll down ADIS' home page for a handful of news items, and see its Therapeutic Updates for summaries of clinical trials as reported in ADIS' other publications. Access to Australia's Current Therapeutics, another ADIS publication, is free to physicians but it takes several days to receive the password via e-mail. Whether it's worth the wait depends on your interest in press-release-type information about a dozen or so new medications released Down Under. ADIS describes itself as a medical publisher and database provider specializing in drug development and disease management, and most of its content is proindustry.

The Washington-based F-D-C Reports targets pharmaceutical and healthcare executives and policy makers, reporting on regulatory, legislative, and business news affecting the drug, biotechnology, device, and cosmetics industries. Its multicolored newsletters on Pharmaceutical and Biotechnology News, Pharmacy News, OTCs and Nutritionals News, Medical Devices News, and Health Policy and Research News post nuggets weekly, or thereabouts.

The Therapeutic Initiative, from the University of British Columbia's Departments of Pharmacology & Therapeutics and Family Practice, provides physicians and pharmacists with bimonthly up-to-date, evidence based, practical information on drug therapy. The Initiative prides itself on being a thoroughly independent organization and on maintaining its database of topical issues since 1994. This is a thoughtful reference reminiscent of The Medical Letter.

Sections Post-marketing

In addition to the FDA's MedWatch described above, private organizations gather and disseminate new information on old medications. The Institute for Safe Medical Practices (ISP), a nonprofit organization and FDA MedWatch partner, has a noisy multi-framed site but occasionally carries important information regarding post-marketing alerts and warnings. The site also supports a public bulletin board full of medical errors, concerns, and questions. ISP is a partner in the Medication Errors Reporting Program, which accepts confidentially submitted information from practitioners. MERP is operated by the United States Pharmacopeia and shares its information with the FDA and relevant pharmaceutical companies. U.S. Pharmacopeia's Practitioners Reporting Network provides access to News, from which current and past medication errors, and quality drug reports can be accessed.

International Pharmaceutical Federation sponsors PharmWeb World Drug Alert Mailing List, to support distribution of information on drugs and medicines.

Sections Investigational Drugs

With varying proportions of altruism and marketing, many universities, hospitals, clinics, and physician home pages present information on experimental therapies and ongoing research. Good starting points for browsing are national sites such as NIH's Clinical Research Studies, Centerwatch's Clinical Trials, AIDS Clinical Trials Information Services, and NCI's Developmental Therapeutics Programs.

The index of articles on new and investigations drugs as reported in F-D-C Reports' The Pink Sheet (see above) is available on line. While extensive, this is not an exhaustive index; only those articles or news items on investigational or newly marketed drugs or biologicals in The Pink Sheet are indexed. Note that the site has a programming bug that brings up the 1998 instead of 1999 brand name table.

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