Document OzGaYE6pz28YVjo4vMrnn9JKe

Voi. 36, Mo. 49 Tl!ADBi*A!!ieS REG. U. S, PAT O FFICE tm a&tisaat pgsss innube A8KI@9 7 8 , 3 . 3 . 23! ./d r m * ... Founded 1939 - $220.00 a yesr i .'i? T,73}.ni{/ ..Oii December 9,1974 tV.v>Ac^ ygfl C a g g ^ S a sg llS -O E ^ ^ ^ g J li^ iia S imnafrias Ir. rete ll FDA, compatitors, comumsrisis Ss others as result of promulgation by Com. ^teedom-of-lnforrKatitm (Fot) regs for aariy pubSccatiorj in Fedsrd Register. y'` -P ol ve provAed on -sejas B-l through 3-3C, iwtireeoptr. Fre ts could, in time, frsve snore profound ircflu&nce on day-to-esy reiationtet'vaen the reguiaied & the ragufatori then enactment of a majrr ires; and asaryens who comes in contact it oi stot. Whan you srste a fette? to cal!, better think haw you would come out if contents of letter cait - sJwxwxJ up is ths W * i 05 4ltety 4 4 feB id coSnmn. D ! PHARMACEUTICAL BOARD CHASRIWASM & OTHER EXECS may have to be more close-mouthed with financial analysts on INBs & NDAs - disclosures can trigger FDA release of other info. REASON: Crucial element in FDA's derision on whether to treat the very existence of an IND and/or NDA file as a non-disclosable secret depends on whether the company or other sponsor keeps the secret. In short, if a company reveals the secret, it can trigger additional disclosures by FDA. After approvable letter issued, FDA discloses summary of data from NDAj all correspondence . . . . . . . . . . . . . . ............................................................................ Pegs A-2 K f l COSMETIC PRODUCT EXPERIENCE REPORTS TO FDA protect names of brands ar.d the mfrs. making voluntary disclosure by Freedom o f Information (Fol) legs. A somewhat different situation is presented by the cosmetic ingre dient and raw materia! composition voluntary reporting system which also was developed by the Cos metic, Toiletry & Fragrance Assn. (CTF) in response to FDA declarations of a need. The new Fol regs do not include a blanket, across-the-board provision - similar to the one covering product experience reporting - that takes care of the confidentiality problem with regard to reporting ingredients and raw material composition................. ............................................... ...................................................... Page A-3 D l DEVICE & DIAGNOSTIC PRODUCT DATA VOLUNTARILY FILED WITH FDA subject to Fol regs. There is no specific provision in the Fol legs covering data on medical devices and diagnostics. In fact, they are mentioned only several times in the lengthy preamble - somewhat in a passing w a y .. Page A-4 THREE KEY DEFINITIONS IN THE Foj_REGS AHE: (a) Trade Secrets; (2) Confidential com mercial or financial information; and (3) Information previously disclosed to the public. Long term effect of regs could be to increase FDA paper flow, dry up personal communications. "Peter's preamble" covers everything, and concludes an invitation to outsiders who disagree to "institute legal action in the courts." Selected quotes from the preamble. Schmidt aside to Kennedy: Unafraid to surface internal memos on controversies; way of science. Page A-5 ^ u JTJtf f s EXHIBIT WCD-181 WCD 001642 A-2 December 9,1974 !?KARMASSLb7!i2A'_ 39AR3 CHAIRMEN & OTHER EXECS SHAT HAVE TO BE S89RE CL9SE-SflSUTHES ViTfH j FlMARCiAi ANALYSTS OH IWDsS MSAs: DSCL0S3ES CAES T3S66ER F3A RfLzftSE Or OTHER K1FO Pharmaceutical industry board chairmen, presidents and financias VPs probably will be more close-mouthed from now on in talking with financial analysts and ethers about new products in the inves tigational New Drug (3ND) or New Drug Application (NDAi stages of R&D as a result of FDA's newly promulgated Freedom o f Information (Fol) regs. ironically, the Fol regs, designed to make FDA the most open agency in all govt. - and its records the most readily available for public disclosure - could result in shutting off the flow of infor mation on research program results and R&D activities from pharmaceutical companies to the public, to the scientific community generally, and to shareholders and financial analysts. REASON: Crucial alaman? in FDA's decision mi whether to tract the very existence of an INO and/or NDA f:ie as a non-disclosabte secret depends on whether the company or other sponsor keeps the secret. In short, if 3 com pany reveals the secret, it can trigger additional disclosures by FDA. Once the secret is out --the existence of an NDA file has been "publicly disclosed or acknow ledged" by the company or sponsor --the FDA commissioner "may, in his discretion, disclose a summary of such selected portions o f the safety and effectiveness data as are appropriate for public consideration of a specific pending issue, e.g., at an open session of an FDA advisory ante." Publicly disclosed or acknowledged, a phrase of art appearing frequently in the Fol regs, is explained in the bible-dimension, 233-typescript-page Peter's Preamble that explains administrative deter minations, FDA commissioner decisions, and even provides learned judicial pronouncements on legal issues. After Apprcvable Letter Issues, FDA Discloses Summary Of Data From NDA; Al! Correspondence After FDA has issued an NDA approvable letter, the existence of the NDA will be disclosed by FDA by placing it on a list of apprcvables maintained by BuDrugs for public inspection. Also, "unless extraordinary circumstances are shown," the following data and information from the NDA file are made immediately available for public disclosure: # "A,summary or summaries of the safety and effectiveness data and information submitted with, or incorporated by reference, in the NDA file." The summaries do not constitute the full reports on the investigations on which the NDA was cleared. For NDAs cleared before July 3, 1975 - starting with the beginning of NDA time - summaries will be prepared from FDA internal documents, with the following deletions: Names and identities of patients, test subjects or investigators; and "any inappropriate gratuitous comments unnecessary to an objective analysis of the data." The summaries to be disclosed for NDAs cieared after July 1, 1975 will be prepared either by BuDrugs or by the sponsor of the NDA, as required by BuDrugs and reviewed by it before release. "A protocol for a test study," unless it can be demonstrated that such protocol is pro tected under the definition of trade secrets or confidential commercial information. 0 "Adverse reaction reports, product experience reports, consumer complaints" and similar data after deletion of identifying names to protect the privacy of individuals who used the product. "A list of all active ingredients and any inactive ingredients" that might have been, pre viously disclosed by the sponsor. WCD 001643 December 9.1974 FDA's Freedom O f Information (Foi) REGS A-3 "An assay method or other analytical method, unless it serves no regulatory or compliance purpose" and can be shown to fall inside the trade secrets or confidential commercial information categories, "All correspondence and written summaries of oral discussions relating to the NDA file" with secrets deleted. Other parts of the regs detail how records of oral discussions are to be kept and ground rules for disclosure of correspondence. FDA will not disclose the following data from an NDA file, even after the cpprovable letter, unless the information has previously been made public by the company or sponsor: "Manufacturing methods or processes, including quality control procedures." "Quantitative or semiquar.titative formulas." `Traduction, sales, distribution and similar data and information" except in FDA compila tions that do not reveal individual secrets. FDA will disclose all safety and effectiveness data in an NDA file when: (1) The NDA has been abandoned; (2) A final determination is made that the NDA is not approvablc; (3) Approval is withdrawn and all legal appeals have been exhausted; (4) FDA determines that the drug is not a New Drug; and (5) FDA decides the drug can be marketed without submission of data. EDITORS1NOTE: See Part 312, INDs, starting at bottom o f page B-24 (white), and Part 314, NDAs, starting on page B-25 (white), in text o f FoS for details. Certifiable antibiotics, New Animal Drug Applications (NADA), and new biological products are subject to similar procedures, outlined in separate sections o f the Fcl regs. -0 - NAMES OF BRANDS & THE MFRS. MAKING VOLUNTARY COSMETIC PRODUCT EXPERIENCE REPDBTSTO FDA PROTECTED FROM DISCLOSURE 3Y FREEDOM OF INFORMATION REGS; INGREDIENT RF.3 DIFFERENT Cosmetic mfrs. and marketers complying with the FDA/CTF voluntary program for filing product experience data with the govt, apparently are protected against disclosure of brand names - and their own names - by across-the-board Section 4.111 of the Freedom o f Information (Fol) regs (see page B-13, white). Whan submitted voluntarily by a mfr., "adverse reaction reports, product experi ence reports, consumer complaints and other similar data," under Section 4.111 (3)(ii}(c> of the Fol regs, will be disclosed to the public only after deletion of "names and any other information that would identify the mfr., or the brand designation o f the product. " The Fol regs state, however, that FDA can disclose the type of product, or its ingredients, in connection with the release of product experience data voluntarily submitted by mfrs. Apparently this refers to the kind of composite cosmetic product experience-figures disclosed in the tabulation presented by FDA Cosmetic Technology Div. Deputy Director John Wenninger at the Dec. 3-4 Food & Drug Law institute meeting in Washington. Included in the tabulation was a column showing the number o f product experiences reported per million units of products distributed, broken down into major categories. A somewhat different situation is presented by the cosmetic ingredient and raw material composition voluntary reporting system which also was developed by the Cosmetic, Toiletry & Fragrance Ass. (CTF) in response to FDA declarations of a need. The new Fol regs do not include a blanket, WCD 001644 A-4 December 9, 1974 across-ihe-board provision - similar to the one covering product experience reporting - that takes care of the confidentiality problem with regard to reporting ingredients and raw material composition. When FDA promulgated the voluntary ingredient reporting reg, it included a provision that the mfr. reporting on a cosmetic product or on a raw material could mark the Report Form "confidential." A procedure was set up so that this would automatically trigger a review by FDA of the confidentiality claim , and i f it was denied, the mfr. could appeal. The new Fol iegs regard all trade information voluntarily filed with EDA as available for disclosure, unless protected by the definitions of trade secrets or confidential commerical information. The regs have no special protection for information voluntarily filed in the past under special programs, and they reject the concept that use of the word "confidential" on any document gives it any special status. A special procedure for "presubmission review of request for confidentiality of voluntarily submitted data" is provided in the new Fol regs (see Section 4.44. page B-8, white). Permission is granted to withdraw the material, i? the "presubmission review" decision is unfavorable. To "deal fairly" with cosmetic mirs. that have already submitted ingredient disclosures, accompanied with confidentiality claims, preamble to the Fol regs says these filings, if not already resolved, will be handled via the new presubmission procedure. If the mfr. who marie the filing doesn't like the decision on confidentiality, the ingredient disclosure data can be withdrawn. With the advent of FDA's regs requiring mandatory label disclosure of cosmetic ingredients, issued under the Fair Packaging & Labeling Law, the voluntary filing program is not so important with regards to finished cosmetic products, but it stilt may be significant in relationship to composition of raw materials. Confidentiality of data filed with FDA in color additive petitions is covered in a special section in the Fol regs, Part 8. Section 8.9 (see page B-20, white). The criteria for determining whether color additive data submitted to FDA should be disclosed are close to those established for drugs, anti biotics, and other areas covered by various forms of licensing. -0 - 'DEVICE & D1AGM0SI1C PRODUCT DATA VOLUftlTARilLY FILED WITH FOA SUBJECT TO Fo! REGS | Large amounts of data have been submitted by mfrs. of devices and in vitro diagnostics to EDA during the past several years on a voluntary basis, chiefly in connection with the classification and standards programs undertaken with the help of outside advisory cmies. . Specific product data undoubtedly was provided in many instances on the basis of informal agreements, spoken understandings, and a general spirit of industry-govt, get-togetherness. The data already in FDA files are now governed by file F ol regs as to disclosure on confidentiality status, regard less of the circumstances under which it was supplied. There is no specific provision in the Foi regs covering data on medical devices and diagnostics, in fact, they are mentioned only several times in the lengthy preamble - somewhat in a passing way. Nevertheless, the general provisions In the Foi regs covering data submitted voluntarily to FDA and determination of confidentiality are applicable to devices and diagnostics. When a new law is passed, devices and diagnostics will still be subject to Fol, but the legal base will shift from voluntary to mandatory. WCD 001645 December 9. 1974 j PDA's Freedom O f Information (Fol) REPS A-5 Xe7 T D Foi REGS: PREVIOUS DISCLOSURE INFORMATION NEGATES ANY CLAIM TO PRCTESTICN AS TRADE SECRETS DR CONFIDENTIAL COitfMERiSAL IBFCRiiiATSO; 'D A a INDUSTRY 1KTO NEW ERA The three key definitions in the Fol regs are: (1) Trade secrets; (2) Confidential commer cial or financial information: and (3) Information previously disclosed to the public. Prior disclosure of information is the most important - from industry's standpoint -- because it negates trade secrets or confidentiality status which would otherwise protect data or information submitted to FDA from becom ing part of the agency's open file. Say the Fol regs: # "Any FDA record mat is otherwise exempt from public disclosure. . .is available for public disclosure to the extent that it contains data or information that have previously been disclosed in a lawful manner to any member of the public, other than an employee or consultant or pursuant tc other commercial arrangements with appropriate safeguards for secrecy." (Sea Section 4.81, p. B-12, white, text of Fol regs.) A trade secret, according to the regs, "may consist of any formula, pattern, device, or compilation of information which is used in one's business and which gives him an opportunity to obtain an advantage over competitors who do not know or use it." (Section 4.61(a), p. B-10, white). "Commercial or financial information that is privileged or confidential," the regs say, "means valuable data or information which ;s used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the per son to whom it belongs." (Section 4.61(b), p. B-10, white). Long-Term Effect Of Regs Could Be To Increase FDA Paper Fiow^ Diy Personal Communications Effective date for the Fol regs is 30 days after publication in the Federal Register, expected in the near future, which would put them into operation sometime in mid-Jan. However, because of the length of the regs and their preamble, written comments or criticisms will be accepted up to 60 days after publication in the Federal Register. There should be very little hope that any written comments submitted in the next 60 days will produce a significant change in even one paragraph or one sentence of the regs. FDA said the com ments should be limited to areas and points not covered in extensive filings made on the original May 1972 proposal, or in the massive preamble to the new regs. Designed to make FDA the most open agency in govt., and hailed as a model for generating a massive new flow of information, the Fol regs, ironicaiiy. conceivably could cut down the movement of information in two key areas: (1) From pharmaceutical board chairmen to security analysts, investors, the public, and science generally because cf the fear that inadvertent disclosures would adversely affect the status of important information irs FDA files; and (2) From FDA's very important mid-level execs who might clam up in discus sions with industry and outside scientists in the face of the prospect that all correspondence and inside memos on telephone calls, et ai, will be released when an NDA is approved. FDA Com. Schmidt, in announcing to a Dec. 3 Food and Drug Law Institute banquet that he had just signed the regs, hailed them as the "most extensive and specific" ever published by any gevt. agency. The regs, he added, "will stand as a monument to Peter Hutt's superb draftsman ship." Schmidt also praised the way FDA bureau heads and staff, plus its Policy Board, had worked WCD 001646 A-6 December 9, 1S74 ail the lengthy text. The "Peter's Preamble" to the regs runs 233 typescript pages, and covers every thing, concluding with an. invitation to outsiders who disagree to "institute legal action in the courts." Selected quotes from the preamble: # "The criteria for a trade secret and for confidential commercial information are sub stantially different The former depends entirely upon the competitive advantage attributable to the specific information involved, whereas the latter may be applicable even if there is n_c specific com petitive advantage involved, if such information is generally held in strict confidence according to usual industry practice. In both instances, of course, lawful prior public release of the information automatically destroys the confidential status o f the information." "Use of an ingredient by more than one mfr. for the same purpose is not, in itself, sufficient to justify a conclusion that such use is not a trade secret. The commissioner recognizes that whether the use of an ingredient constitutes a trade secret will depend upon a number c f factors, and primarily whether it has previously been disclosed to the public. . . # "A representation by a company that, to the best of its knowledge and belief, the in gredient has not previously been disclosed to any member c f the public, will be sufficient to create a prima facie case of confidentiality, which may be rebutted by FDA, if it determines that the ingredient has in fact become public knowledge." # "Any letters to or from a member of Congress, as weli as summaries of oral discussions, regardless of whether the member is acting in an official capacity or as a member of a duly authorized cmte., will be available for public disclosure except to the extent that the correspondence contains trade secrets or other nondisclosable information." hchmidt Asida To Kennedy: Unafraid Yo Surface Ir.tereial jVjemos On Controversies; Way Of Science "FDA has received a number of requests with respect to prior employment experience of present agency employees, and present employment of past agency employees. Although no such lists had been kept in the past, the commissioner concluded that research should be undertaken in order to respond adequately to inquiries of this type." "Experience during the past two years has shown that mfrs. and MDs are uniformly un willing to divulge consumer complaint or adverse reaction information, or other materials of this type, voluntarily except on a pledge of confidentiality." 0 "A list of all drugs subject to Investigational New Drug notices constitutes trade secret information that may not be disclosed to the piblic." "The commissioner will issue in the near future comprehensive new procedural regs. . . that will include provisions governing all aspects of the activities of the advisory cmtes." "Private acknowledgment of the existence of an IND to a consultant is insufficient to constitute public disclosure. Discussion with other scientists who are not paid consultants, however, or with securities analysts, or acknowledging the existence of an IND to any such person, is sufficient to break the confidentiality o f the existence of an IND. The commissioner notes that the existence of an IND is often common knowledge within the industry and the scientific world, and ihat confidentiality of such information is becoming more and more unusual." Re disclosure of internal FDA memos showing controversies and reversals of recommenda tions: "the commissioner believes that such disclosure wili not harm the regulatory efforts of the agency, but indeed will serve to foster better public understanding cf the internal discussion about scientific and medical issues that must always characterize an open and responsive regulatory agency." WCD 001647 [Text: FDA Freedom o f Information Regs] FDA's Freedom O f Information (Fol) REGS; FULL TEXT, AS SIGNED BY COM. SCHiVHDT EDITORS" NOTE: Prepared from a certifiedtypescript copy, scheduled fo r Federal Register publication in near future. N o deletions except fo r statutory references. Abbreviations are those used regularly b y "The Pink S h e e t." Screening, occasional paragraphing, graphic makeup devices added. See page B-2 fo r section-by-section index o f Part 4 - Public Information - the across-tbe-board regs, with page-number references supplied b y the editors. See page B-15 fo r list o f 2 8 sections and paragraphs in already existing FDA regs which are am ended b y Part 4; 17 o f these are included with am end m ents in prom ulgated version o f F o l regs. SUBCHAPTER A - GENERAL PART 1 -- REGULATIONS FOR THE ENFORCEMENT OF THE FD&C ACT & THE FAIR PACKAGING & LABELING ACT 1. In Part 1, by adding a new paragraph (c) to 1.6 to read as follows: S 1.6 Presentation of views under section 305 of he act. (c) Records relating to this proceeding constitute investigatory records for law enforcement purposes and may include inter- and intra-agency memoranda. (15 Notwithstanding the rule established in S 4.21 of this chapter, no record relating to a section 305 hearing is available for public disclosure prior to the consideration of criminal prosecution based upon that record being closed, except as provided in S 4.82 of this chapter. The Commissioner will exercise his discretion to disclose records relating to a section 305 hearing pursuant to 4.82 of this chapter prior to the consideration o f criminal prosecution being closed only very rarely and only under circumstances that demonstrate a compelling public interest. (2) After the consideration of criminal prosecution is closed, such records are available for public disclo sure except to the extent that the exemptions from disclosure in Subpart D of Part 4 of this chapter are applicable. No statements of witnesses obtained through promises of confidentiality are available for public disclosure. (35 The consideration of criminal prosecution based upon a particular section 305 hearing shall be deemed to be closed within the meaning of this section when a final decision has been made not to recommend criminal prosecution to a U.S. attorney based upon that hearing, or such recommendation has been finally refused, or criminal prosecution has been instituted and the matter and ail related appeals have been concluded, or the statute of limitations has run. (4j Prior to disclosure of any record specifically reflecting consideration of possible criminal prosecution of any individual, all names and other information that would identify an individual who was considered for criminal prosecution but who was not prosecuted shall be deleted unless the Commissioner concludes that there is a compelling public interest in the disclosure of such names. (5) Names and other information which would identify a F D A employee shall be deleted from section 305 hearing records prior to public disclosure only pursuant to 4.32 of this chapter. PART 2 - A D M IN IST R A T IV E FUNCTION, PRACTICES, & PROCEDURES Subpart G - Public Information 2. In Part 2, by deleting Subpart G - Public Information containing 2.115 Fee schedule fo r searching, supplying, and certifying records. Concurrently, the information in this subpart is being recodified into Part 4 as 4.42. 3. By revising Part 4 to read as follows: [B-1] WCD 001648