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Understanding the regulatory environment

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Research background: Since its inception, the biotechnology industry has been regulated by the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA).

On September 6, 2002, the FDA announced its decision to move this responsibility to the Center for Drug Evaluation and Research (CDER).

BLA Biologics is a biotechnology company that is developing therapeutics using pure monoclonal antibodies.

The regulatory affairs department head has seen the September 6 press release and wishes to know whether oversight of therapeutic monoclonal antibodies remains with CBER or will move to CDER.

She needs to determine whether the company’s products will be affected and when the changes are likely to take place, and she approves the hiring of an independent research consultant to find out. The search is conducted in early November 2002.

Research budget: The department head knows that FDA approval is essential for the success of BLA Biologics’ business.

She has authorized up to $200 in database costs and eight hours for research, analysis, and preparation of a report.

Research strategy employed: The researcher will take a three-part approach.

1. Check the FDA Web site for announcements following the press release.
2. Search periodicals databases for pertinent reporting and analysis.
3. Return to the FDA Web site to obtain contact information by which the client can receive timely updates.

Research results: The results can be summarized in three steps as follows:

Step 1. Check the FDA Web site for announcements following the press release.
To find the FDA Web site, the researcher types FDA into the search box of the Web search engine Google (http://www.google.com).

He then clicks the link to the FDA home page (http://www.fda.gov). On the home page he clicks a link to press releases (http://www.fda.gov/opacom/hpnews.html).

On the press release page, the titles are listed in reverse chronological order. Scrolling down to early September 6, 2002, press release and sees that there are no subsequent releases on this topic as of early November.

Clicking on the title f the press release takes him to the text, where he finds that the agency expects to develop an action plan and timeline by January 2003. In the interim, companies are advised to continue in their relationships with CBER or CDER.

The researcher would like to find a specific statement regarding the review of monoclonal antibodies under the new system.

The FDA site is complex, and there is not an obvious route to the answer by simply following links, so he will use the site’s search capability.

He selects the Advanced Search option to obtain as much precision as possible. On the Advanced Search page he selects Search Tips to find the most effective way to structure his queries. The list of tips tells him the following:

1. AND is automatically entered between terms (i.e., all of the terms entered will be present in each search result, though they won’t necessarily be adjacent or present in the order entered).

2. Common words such as “where” and “how” are automatically excluded unless they are included in a specific search phrase, described below.

3. The search is not case-sensitive, so it doesn’t matter whether you enter cder or CDER.

4. Only the specific word is searched; there is no stemming or wild card search. So the researcher will have to search separately for similar terms, such as “antibody” and “antibodies.”

5. There is no OR connector term, so the researcher will have to run separate searchers for synonymous terms or phrases.

The Advanced Search page contains three sections (see Figure 3-5). The first section, Find Results, is for entering the search terms and includes four search boxes.

The researcher examines the press release and chooses keywords based on the terminology there. In the box for “with all of the words” he enters consolidation.

He also enters September 2002 to exclude older items; he will try October 2002 in a second search.

The second section of the advanced search page, labeled Occurrences, allows the user to specify where the search terms appear: anywhere in the document, in the title, or in the URL. The researcher indicates that the terms may appear anywhere in the document.

The third section, labeled Categories, allows the user to specify the type of page in which the search terms appear. The researcher selects “All of the FDA Website.”
Among the first hits retrieved are the following two relevant items:

(1) a presentation by the deputy commissioner of the FDA given at an FDA/PDA conference in September 2002 (http://www.fda.gov/oc/seeches/2002/pda0924.html) and

(2) the October 2002 issue of CDER News Along the Pike (http://www.fda.gov/cder/pike/septoct2002.htm).

The first does not include any substantive information that adds to the information given in the press release.

The second item announces that monoclonal antibodies are among the products whose review will be transferred from the CBER to CDER. Repeating the search using October in place of September does not produce any more useful items.

Step 2. Search the periodicals databases for pertinent reporting and analysis.
For investigative reporting and analysis, the researcher now turns to the periodicals databases offered by Dialog (http://www.dialog.com) and Factiva (http://www.factiva.com).

He will compare (1) a cost-conservative approach using DialogWeb, (2) a more comprehensive search using DialogClassic, and (3) a search using Factiva.

The following search string is used in all three searches, with slight variations in syntax specific to each database provider: fda AND consolidat? AND product review? AND PD = 020906:021031.

1. A cost-conservative approach using DialogWeb. Logging on to DialogWeb, the researcher clicks on Industries and Markets within the Medicine and Pharmaceuticals Supercategory.

Within this category, he has several choices. Clicking on Pharmaceutical Regulation reveals that the category offers twelve databases; Regulatory News offers five databases; Industry News: Pharmaceutical offers thirty-three databases.

Within this window the Targeted Search: Pharmaceutical News (eight databases) provides a cost-conservative approach.

He leaves the Company and Title boxes blank and enters the search string in the Text box. The search is case-insensitive.

He truncates consolidation, using the wild card symbol (question mark) to find variants such as “consolidate” and “consolidated.”

To find the exact phrase product review, he uses empty parentheses, which is a shortcut for typing the WITH (w) connector. This means the two terms must be adjacent and in the order specified. He specifies date limits in the Year pull-down menus.

The researcher examines the titles found and selects those that appear relevant by clicking on the boxes to their left.

Then he chooses a destination from the pull-down menu at the top of the window and clicks Display/Send. One article, dated September 16, says, “CDER emphasizes that it does not expect to be asked to redo any work already completed by CBER.

The biotechnology sector, in particular, is concerned that the transfer yield minimal disruption in pending applications (see preceding story).”

The same source names the key personnel involved in decision making. Another source, dated October 21, yields the following information: “Crawford said the FDA will have the transfer of therapeutic biologics from CBER to CDER effectuated by the end of the year, but may be not much before then.”

It further says that the “FDA’s working group on the CBER/CDER reorganization, chaired by Senior Associate Commissioner Murray Lumpkin, MD, met Oct. 17 and is expected to develop by January an implementation action plan and timeline for the consolidation, which will address logistical issues.” The cost of this search was $27.76.

2. A more comprehensive search using DialogClassic. To compare these results with a more through search, the researches will start with DIALINDES (File 411) in DialogClassic, screening all files except newspapers for hits that match the search string.

Explanations of the search commands and categories for DIALINDEX can be found on its Bluesheet (http://library.dialog.com/bluesheets). The sequence of commands is as follows:

• BEGIN 411 (This opens DIALINDEX.)
• SF ALL NOT PAPERS (This tells DIALINDEX to search all files except the newspapers.)
• S FDA AND consolidat? AND product()review? AND PD=020906:021031(S is the abbreviation for “select.” The convention for specifying dates is yymmdd.)
• SAVE TEMP PHARM (This saves the search string so the researcher doesn’t have to type it again when he leaves File 411 to search other files.)
• BEGIN HITS (This opens all the files that contain “hits’ or articles found by the search.)
• EXS (This runs the saved search in the files just opened.)
• RD (This is short for Remove Duplicates. Some of the databases searched have overlapping content, so some articles are found more than once.)

After removing duplicates, this search yields the same four relevant articles, at a cost of $41.98.

Subsequent monitoring of the print media can be done more economically as a targeted search of Pharmaceutical News, or even more economically by monitoring File 187 (F-D-C Reports), which gave the most useful articles.

What happens if the researcher uses a broader search string? Returning to the press release, he sees that “reorganization” is sometimes used in place of “consolidation,” and that “review” can appear with “product(s)” or “biologic(s).”

Thus, he can search the expanded string: s fda AND (conslidat? OR reorganiz?) AND (product? OR biologic?(n)review?). This yields thirteen more hits, including some useful quotes analysis by leaders or former executives in the industry and the FDA.

Among these, a September 30 article in the San Diego Business Journal quotes a trade group: “There is hope the move will speed up the review of drug applications, because the Center for Drug Evaluation and Research, or CDER, is more experienced and has a better track record in evaluating drugs.”

This article also lists a possible source of assistance outside the FDA, the Biotechnology Industry Organization.

“The nation’s largest trade group, [the BIO] has organized a CDER-CBER taskforce to help with the transition, according to BioCentury, a biotechnology newsletter.” Other sources identify possible changes that may occur under the new system.

Additional articles provide more commentary, but no new facts practical use for the client.

The cost of the expanded search: $59.20. All of the prices cited include the charges for full-text articles retrieved.

3. Search using Factiva. Turning to Factiva (http://www.factiva.com), the researcher runs the same search, obtaining eight hits, of which three appear relevant:

• “FDA Restructures New Product Review Centers.” Nature Biotechnology 1 (October 2002).

On September 6, the FDA announced that it will consolidate its two new drug product review centers into a single center to be called the Center for Drug Evaluation and Research. The center will be based in Rockville, Maryland. One goal of . . .

• “FDA Deputy Commissioner Presentation at Parenteral Drug Association Conference Biomedical Market Newsletter,” September 30, 2002. Lester M.

Crawford, Jr., D.V.M., Ph.D Deputy Commissioner U.S. Food & Drug Administration Washington DC Sept. 24, 2002. “As you just heard, I first joined the FDA 27 years ago. Now that I am back on my fourth tour with the agency, I find . . .”

• “US FDA Consolidates New Drug Review. (Brief Article).” Marketletter 16 September 2002.

The US Food and Drug Administration’s responsibility for reviewing new pharmaceuticals, currently conducted at both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, is to be consolidated into . . .

The first item is a one-paragraph document that yields no useful information. The researcher recognizes the second item as the text of a speech that also is posted on the FDA Web site.

The third item contains the statement that a timeline for consolidation is expected by January 2003.

Overall, the concise Factiva search yielded less information, but at a cost of $2.95 per article retrieved with no search costs, it was worth checking.

Running the broader search string on Factiva yields thirty-one hits, many of which are duplicate newswire items.

Five of the hits offer substantive analyses. They provide some interesting political insights, but no information that addresses the client’s primary questions.

Step 3. Return to the FDA Web site to obtain contact information by which the client can receive timely updates.

The researcher hopes that the FDA Web site will provide contact information for FDA staff who can provide the most current information on product submissions during the transition period.

Following the links from the home page (from Contact FDA to Regulated Industry) he finds a page of links (http://www.fda.gov/oc/industry/default.htm), including What’s New at FDA From here he clicks the Subscribe to Email Lists link (http://www.fda.gov/emaillist.html).

This takes him to a collection of links to e-mail lists that provide news from various FDA departments.

The following choices appear useful:
• FDA News Digest: Current FDA activities, with links to press releases, talk papers, and more

• Center for Drug Evaluation and Research: Daily or weekly notices of new additions to the CDER Web site

• Center for Biologics Evaluation and Research: Lists for blood product recalls and other CBER information

Under the heading Contact the FDA, the researcher follows the Ombudsman link (http://www.fda.gov/oc/ombudsman/homepage.htm).

The Office of the Ombudsman lists as one of its roles “to determine appropriate classification and regulatory pathway for combination products and for drug, device, and biological products when the jurisdiction of a product is unclear or in dispute.”

On this page, the link How to Contact the Ombudsman (http://www.fda.gov/oc/ombudsman/howcon.htm) provides postal and e-mail addresses, and telephone and fax numbers.

Also under the Contact the FDA heading is an employee directory that is searchable by name or browsable by department.

Summary of solution: According to statements on the FDA Web site, the review of therapeutic monoclonal antibodies will be transferred from CBER to CDER, and until the logistics of transfer are worked out, companies are advised to continue in their relationships within CBER or CDER.

Turning to Dialog to examine articles from trade journals, the researcher has found the names of key decision-making personnel within the FDA and the prediction that the action plan for consolidation will be developed by January 2003.

He has also found that opinions of industry insiders vary on whether the consolidation will speed or impede the review process. F-D-C Reports (File 187 on Dialog) has turned out to be a good source to monitor for reporting and analysis as consolidation of the centers progresses.

The database plus document costs came to $59.20.
Returning to the FDA Web site, the researcher found the following:

• How to subscribe to FDA-produced e-mail lists that provide news about general FDA news and news specific to each center (http://www.fda.gov/emaillist.html)

• How to contact the Office of the Ombudsman (http://www.fda.gov/oc/ombusman/homepage.htm)

• Links to an employee directory that is searchable by name, agency, or job title (http://directory.psc.gov/employee.htm) or browsable by department (http://directory.psc.gov)

The regulatory affairs department head concludes that the transfer will not affect the BLA Biologics products already in review; later submissions will be affected, but it is not clear when the transfer will take effect.

She decides to monitor developments and consult FDA personnel to determine which center should receive submissions after the first of the year.

The total cost of the data from this search came to $150.65 for a thorough search of two database services.

Total time spent searching, reading, organizing information and preparing a report was about eight hours.

Useful tips
• When you are faced with a large and complex Web site, using the site’s search tool can save you time.

• Many search forms provide a link to “search tips” that help you choose the most effective search syntax.

• For a simple, focused search, DialogWeb is easy to use. For a comprehensive search, start with DIALINDEX to find all available sources.

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