OPHS — Medical Marijuana: Request for Reconsideration (RFR)

05/19/2005

Subject: Information Quality Appeal

Re: HHS Review of the 1995 Marijuana Rescheduling

Petition: 66 Federal Register 20040 (April 18, 2001) at pages 20039 & 20051-52

Americans For Safe Access, On Behalf Of Its Individual Members', Appeal Requesting Correction Of HHS Response To 1995 Marijuana Rescheduling Petition

Date: May 19, 2005

VIA ELECTRONIC TRANSMISSION AND OVERNIGHT MAIL

Department of Health and Human Services, Food and Drug Administration, Office of the Ombudsman 
5600 Fishers Lane, Room 14B03, HF-7, Rockville, MD 20857 
informationquality@oc.fda.gov

Dear Sir or Madam:

In the interest of protecting the health and well-being of seriously ill persons who are suffering pain and other deleterious effects from following the Department of Health and Human Services' ("HHS") statements that marijuana does not have any medical use, Americans for Safe Access ("ASA") seeks reconsideration of your response to our October 4,2004, Data Quality Act Request for Correction. That Request was constructively denied by HHS by letter, dated April 20, 2005. HHS's failure to correct its inaccurate statements that marijuana lacks medical use violates the goal of the Data Quality Act, Paperwork Reduction Act, 44 U.S.C. § 3516 Statutory and Historical Notes, P.L. 106-554, as well as its own implementing Guidelines, of ensuring the timely flow of vital health and safety information to the members of the public. As a result, many of ASA's members will continue to suffer.

I. Procedural History

On October 4,2004, ASA submitted a Request for Correction of the specified portions of the HHS review HHS Review of the 1995 Marijuana Rescheduling Petition, 66 Federal Register 20040 (April 18, 2001) at pages 20039 & 20051-52. (See Exhibit A) As required by the HHS and FDA Guidelines, ASA's Request provided all the necessary information: 
(1) a detailed description of the specific material to be corrected; 
(2) the specific reasons and supporting documentation for believing that the information does not comply with OMB, HHS and FDA guidelines and is in error; 
(3) the specific recommendations for correcting the information; 
(4) a description of how ASA and its membership is affected by the information error, and 
(5) contact information for the individual submitting the request on ASA's behalf.

Without objection to the format, and without seeking further information :trom ASA, Dr. Steven Galston, Acting Director, Center for Drug Evaluation and Research, Food and Drug Administration, HHS, responded by letter, dated December 1,2004, which stated that HHS would be consulting with the National Institute on Drug Abuse and the Drug Enforcement Administration in preparing its response and that it hoped to provide such response within an additional 60 days. Dr. Galston further stated that the delay was occasioned by "other agency priorities and the need to coordinate agency review of the response." (See Exhibit B)

In response, by letter dated December 20, 2004, ASA protested that HHS was inexcusably expanding its inquiry to include considerations outside the scope of ASA's Request for Correction and that such expansion would unduly delay an administrative response to ASA's Request.(See Exhibit C) HHS did not respond to this letter and, instead, by letter dated February 2,2005, responded that it would be unable to respond to ASA's Request for Correction within the additional 60 days and that it anticipated that it would do so by April 1, 2005. (See Exhibit D)

On April 5, 2005, Laurie Lenkel :trom the Office of the Ombudsman, Office of the Commissioner, HHS, sent ASA another letter delaying the agency response, yet again, to April 15, 2005. (See Exhibit E) Then, by letter dated April 20, 2005, RADM Arthur L. Lawrence, Assistant Surgeon General, informed ASA that HHS would not act on its Data Quality Act Request, but would instead considered the information presented thereby in connection with a petition to reschedule marijuana, which has been pending since 2002. (See Exhibit F) This denial of ASA's Request for Correction states as follows: 
Both the Office of Management and Budget (OMB) and the HHS Information Quality Guidelines provide that federal government agencies may use existing processes that are in place to address correction requests :trom the public. In the case of marijuana, HHS currently is in the process of conducting a review in response to the petition for change that was submitted to DEA in October 2002 by the Coalition for Rescheduling Cannabis (CRC), an association of public-interest groups and medical cannabis patients that includes ASA. [footnote omitted] In the course of the review, HHS will evaluate all the publicly available peer reviewed literature on the efficacy of marijuana.

(Exhibit F at 2)

II. Specific Reasons Why HHS's Response is Inadequate

Under HHS's own Information Quality Act Guidelines, the agency has a responsibility to respond to requests for correction of information in a prompt and timely manner. To this end, the HHS Guidelines state in the section entitled "Responsibility of the Agency" that "[t]he agency will respond to all requests for correction within 60 calendar days of receipt." Furthermore, agencies responsible for dissemination of "vital health and medical information" have additional responsibilities to "ensur[ e] the timely flow of vital information from agencies to medical providers, patients, health agencies, and the public." (HHS Guideline D.2.c.2.) In short, the Data Quality Act and the HHS Guidelines require prompt consideration of a request for correction of information, especially where vital health and medical information is at issue.

Nor can HHS evade its responsibilities under these temporal requirements by lumping a request for correction of information under the Data Quality Act together with a distinct, farther­reaching and much slower process. While the HHS Guidelines provide that the agency may use existing procedures to respond to information quality complaints that arise in "rule-making and other formal agency actions [that] already provide well established procedural safeguards that allow affected persons to raise information quality issues on a timely basis," no such procedures exist for a marijuana rescheduling petition. That process is slow. One such petition was pending for more than twenty-two years.(See Alliance for Cannabis Therapeutics v. DEA, 15 F .3d 1131, 1133 (D.C. Cir. 1994» Another for more than six. (See Gettman v. DEA, 290 F.3d 430 (D.C. Cir. 2002» And the current petition has been pending for nearly three years, with no end in sight. Unlike the discrete and specific requests for correction of information by ASA regarding the efficacy of marijuana for medical use (see Exhibit A), the pending marijuana rescheduling petition involves additional considerations, such as whether marijuana presents a "risk to public health" and whether it has a "high potential for abuse" under 21 U.S.C. § 812(B)(1)(a). HHS is violating both the letter and the spirit of the Data Quality Act, as well as its own Guidelines, by delaying indefinitely its review of ASA's Request for Correction by transferring the substance of that request to another agency.1

Meanwhile, medical marijuana patients and putative medical marijuana patients will be paying a steep price. As was stated in ASA's Request for Correction, medical marijuana patients suffer reduced access to medical marijuana, and doctors are chilled from discussing it with their patients, by the HHS's dissemination of scientifically flawed information that marijuana lacks currently accepted medical use. In particular, persons who would otherwise become medical marijuana patients to alleviate their suffering are deterred from doing so by the false information disseminated by HHS. Exacerbating this, doctors are unwilling to discuss the medical benefits of marijuana with their patients because ofHHS's statements. (See Doblin, Richard and Kleiman, Mark, "Marijuana as Antiemetic Medicine: A Survey of Oncologists' Experiences and Attitudes," Journal of Clinical Oncology 9(7), at pp. 1314-1319 (1991) (reporting that 48% of oncologists would recommend marijuana to at least some of their patients if it were legal).

Even in cases where a request for correction is made to review information disseminated in connection with another pending HHS action, the HHS Guidelines require -- in a provision ignored by the agency's response -- that the agency consider the request for correction prior to the final agency action where an earlier response "would not unduly delay issuance of the agency action or information product and the complainant has shown a reasonable likelihood of suffering actual harm ITom the agency's dissemination ifthe agency does not resolve the complaint prior to the final agency action or information product." (HHS Guidelines, Section E) Here, a prompt response to ASA's Request would expedite, rather than delay, the DEA's consideration of the pending marijuana rescheduling petition and, in the interim, seriously ill persons represented by ASA are suffering ITom being misled about the medical benefits of marijuana. HHS should act on ASA's Request for Correction.

Dated: May 18, 2005

Respectfully submitted,

Joseph D. Elford

Attorney for Petitioner, Americans For Safe Access

Note: 
1Even if the marijuana rescheduling petition resulted in the rescheduling of marijuana ,HHS would still have to act on ASA's Request for Correction, since such decision would not change the inaccurate statements made by HHS in 1995, which continue to be disseminated.