Wednesday, March 25, 2009

Senator Grassley asks for clarification from the FDA

In response to a memo sent out from the FDA reminding employees to not disclose information outside of the FDA, Senator Grassley has sent a letter to acting chief of the FDA to remind them that interfering with whistle blowers is illegal.

Here is a link to the letter on the Senate Finance Committee website.


Senator Grassley is a long time advocate of whistle blower's rights. In the letter he makes the point that the memo last week from the FDA to employees was ill timed in the light of some recent investigations going on at the FDA:

"My concern is that this recent memorandum could be viewed by some as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws to communicate with Congress.

Fox example, internal FDA documents released recently seem to suggest that lobbying may have influenced the decision in a device approval.[1] Another internal document shows that a physician was removed for inappropriate reasons from a recent safety panel.[2] In both, cases, I do not believe that Congress would be notified unless whistleblowers spoke up. "

Senator Grassley is asking the acting Chief of the FDA to issue a second memorandum clarifying the situation and ensuring that would be whistle blowers are unencumbered in their rights to speak to congress and the FDA's obligation to honor those rights.

Let's keep an eye on this one...


  1. Yeah right.

    See the comments on the following article.

  2. Here is the text of Grassley's letter to Torti:

    March 24, 2009

    Frank M. Torti, MD, MPH

    Acting Commissioner

    U.S. Food and Drug Administration

    5600 Fishers Lane

    Rockville, MD 20857

    Dear Dr. Torti:

    As a senior member of the United States Senate and the Ranking Member of the Committee on Finance (Committee), I have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the activities of the Food and Drug Administration (FDA/Agency). In this capacity, I work to ensure that FDA is completing its mission to protect the public's health and makes responsible use of the public funding provided for medical studies. Decisions made by FDA often form the basis for action taken by the Medicaid and Medicare programs which fall under the exclusive jurisdiction of the Committee.

    I am concerned about a recent memorandum you sent to FDA employees warning them of their obligations to keep certain information confidential. While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

    Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.

    I appreciate your concerns with protecting confidential information from unauthorized disclosures. These protections play an important role in allowing business and industry to work cooperatively with regulatory agencies. However, I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA's regulatory mission. My concern is that this recent memorandum could be viewed by some as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws to communicate with Congress.

    Fox example, internal FDA documents released recently seem to suggest that lobbying may have influenced the decision in a device approval.[1] Another internal document shows that a physician was removed for inappropriate reasons from a recent safety panel.[2] In both, cases, I do not believe that Congress would be notified unless whistleblowers spoke up.

    Dr. Torti, I have been an outspoken advocate for whistleblowers and have authored numerous whistleblower protection provisions. Whistleblowers are some of the most patriotic people I know-men and women who labor, often anonymously, to let Congress and the American people know when the Government isn't working so we can fix it. As such, it would have been prudent for you to include a section in your memorandum that outlines the interplay between protected confidential and trade secret information and making protected disclosures to Congress and/or Inspectors General in accordance with the whistleblower protection laws. Absent such a discussion, many FDA employees could take this memo to mean that they could be criminally sanctioned for providing information to Congress.

    As you may be aware, 18 U.S.C. § 1505 states, in pertinent part:

    Whoever corruptly, or by threats or force, or by any threatening letter or communication influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due and proper administration of the law under which any pending proceeding is being had before any department or agency of the United States, or the due and proper exercise of the power of inquiry under which any inquiry or investigation is being had by either House, or any committee of either House or any joint committee of the Congress--

    Shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2331), imprisoned not more than 8 years, or both.

    Additionally, denying or interfering with employees' rights to furnish information to Congress is also against the law. I have attached another copy of 5 U.S.C. § 7211 to this letter for your reference. That law states:

    The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied.

    Finally, federal officials who deny or interfere with employees' rights to furnish information to Congress are not entitled to have their salaries paid by taxpayers' dollars. I have attached a copy of P.L. 111-5 § 714 to this letter for your reference, which states:

    No part of any appropriation contained in this or any other Act shall be available for the payment of the salary of any officer or employee of the Federal Government, who -

    (1) prohibits or prevents, or attempts or threatens to prohibit or prevent, any other officer or employee of the Federal Government from having any direct oral or written communication or contact with any Member, committee, or subcommittee of the Congress in connection with any matter pertaining to the employment of such other officer or employee or pertaining to the department or agency of such other officer or employee in any way, irrespective of whether such communication or contact is at the initiative of such other officer or employee or in response to the request or inquiry of such Member, committee, or subcommittee; or

    (2) removes, suspends from duty without pay, demotes, reduces in rank, seniority, stats, pay, or performance of efficiency rating, denies promotion to, relocates, reassigns, transfers, disciplines, or discriminates in regard to any employment right, entitlement, or benefit, or any term or condition of employment of, any other officer or employee of the Federal Government, or attempts or threatens to commit any of the foregoing actions with respect to such other officer or employee, by reason of any communication or contact of such other officer or employee with any Member, committee, or subcommittee of the Congress as described in paragraph (1).

    FDA employees have the right to talk to Congress and to provide Congress with information free and clear of Agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal. You should review these important statutes and reevaluate the message sent by your memorandum. I believe that you should take the further step of issuing a second memorandum to FDA employees outlining their rights and whistleblower protections, as well as outlining the FDA's responsibilities for respecting those protected disclosures. Such a memorandum would go a long way toward ensuring that the FDA remains "committed to the principles of open Government and transparency" as you stated in your memorandum.


    Charles E. Grassley

    Ranking Member


    By Anonymous | Posted 6:57pm | March 25, 2009

    Big Deal.

    Grassley just keeps saying this and FDA keeps just ignoring him. In fact FDA management has already fired reviewers and had them halled from the building by security for openly complaining to Senator Grassley about FDA officials colluding with drug companies to put clearly unsafe and ineffective drugs on the market.

    But don't fear after you've been maimed FDA is working with the drug companies to approve treatments for your drug induced disease (if you survive that long).

    Grassley has the e-mails and the proof and FDA knows it. So Torti knows he can just thumb his nose at Congress and nothing is going to happen.

  4. Anon.

    I'm not totally following. If Grassley has the emails, and FDA knows it, why can Torti just thumb his nose? Because Grassley hasn't done anything besides make noise? Is that the point?

  5. Below is a copy of Dr. Torti's original memo:

    From: A Message from the Commissioner
    Sent: Friday, March 13, 2009 3:52 PM
    To: FDA-Wide
    Subject: Protecting Confidential Information
    FDA is committed to the principles of open Government and transparency, as outlined in the
    Presidential Memoranda of January 21, 2009. At the same time, FDA must comply with its
    obligations to keep certain information in its possession confidential. The statutes, regulations, and
    policies under which FDA operates require that certain information in the agency's possession be
    kept confidential except in certain, often narrow, circumstances where disclosure is authorized by
    law and all procedural safeguards (such as management concurrence) have been satisfied. Among
    the laws governing disclosure or requiring confidentiality are the Federal Food, Drug, and Cosmetic
    Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as
    FDA’s implementing regulations. Violation of these provisions can result in disciplinary sanctions
    and/or individual criminal liability. Improper disclosure could also result in FDA being sued for
    It is imperative that all of us ensure that we are vigilant in fulfilling our critical responsibility to
    safeguard information entrusted to the agency, and I know that I can count on you to comply with all
    applicable confidentiality requirements. Determinations regarding disclosure are to be made through
    the designated FOIA/Privacy Act contacts in your organization following agency procedures.
    The information in question generally falls under, but is not limited to, one of the following
    1. Trade Secrets. A trade secret is a commercially valuable plan, formula, process, or device that is
    used for the making, preparing, compounding, or processing of trade commodities and that can
    be said to be the end product of either innovation or substantial effort. There must be a direct
    relationship between the trade secret and the productive process. Examples of trade secrets
    include materials used in manufacture which are not immediately identifiable, manufacturing
    processes, quality control procedures, sterilization techniques, and formulas that are not on the
    product labeling. Among other documents, trade secrets are frequently found in Establishment
    Inspection Reports (EIRs) and pre-market applications.
    2. Confidential Commercial Information (CCI). Confidential commercial information is valuable
    data or information used in one's business that (a) if voluntarily submitted to FDA, is of the type
    customarily not disclosed to the public by the person to whom the information belongs, or (b) if
    not voluntarily submitted to FDA (e.g., if required for certain product approvals), is information
    which, if disclosed by FDA, would be likely to cause substantial harm to the competitive
    position of the person to whom the information belongs or would impair the agency's ability to
    obtain similar information in the future. Examples of CCI include safety and effectiveness and
    other research data, sales statistics, customer and supplier lists, profit and loss data, overhead and
    operating costs, and other financial information. CCI is often found in the same kinds of
    documents that contain trade secrets.
    3. Personal Privacy Information. Personal privacy information is information the disclosure of
    which would constitute a clearly unwarranted invasion of privacy. Examples of such
    information can include the names of patients (or other personal identifying information about
    patients) in clinical trials, the names of persons, including physicians, who voluntarily submit
    adverse experience reports or consumer complaints, and the vast majority of information in
    personnel files (including social security numbers and other personal identifiers, home addresses,
    bank account numbers, etc.). It also includes information protected under the Privacy Act.
    4. Privileged Intra-agency and Inter-agency Documents. This covers, for example, internal
    memoranda, letters, and e-mail to and from employees within FDA (intra-agency) and to and
    from FDA and other Government agencies (inter-agency). The most common privileges include
    (a) the deliberative process privilege, which protects the pre-decisional advice, opinions, and
    recommendations of agency employees; (b) the attorney-client privilege, which protects
    confidential communications between FDA and its attorneys related to a legal matter for which
    FDA has sought legal advice; and (c) the attorney-work product privilege, which protects
    documents and other memoranda prepared by an attorney for FDA in contemplation of litigation.
    Examples of documents that might contain this kind of information include drafts of policymaking
    documents, draft notices of proposed and final rules, drafts of other Federal Register
    documents, recommendations to take (or not to take) some regulatory or enforcement action,
    requests for legal opinions and the opinions themselves, etc.
    5. Law Enforcement Records and Information. This covers a wide assortment of information that
    is compiled for law enforcement purposes if disclosure of the information, among other things,
    (a) could reasonably be expected to interfere with enforcement proceedings, (b) could reasonably
    be expected to disclose the identity of a confidential source, (c) could reasonably be expected to
    constitute an unwarranted invasion of personal privacy, or (d) would disclose law enforcement
    procedures and techniques if such disclosure could reasonably be expected to risk circumvention
    of the law. Examples of such documents include Establishment Inspection Reports (EIRs),
    memoranda, and other documents relating to an investigation. Certain of these documents may
    be disclosed once the investigation or matter is closed.
    For more information about these and other categories of information that we must keep
    confidential, please refer to Staff Manual Guide 2280.10, Protection of Non-Public Information
    (NPI) available at
    7444.html. In addition, the FY 2009 ISSO Online Computer Security Awareness Training course
    includes a module describing FDA's security policies and procedures regarding the protection of
    non-public information and is available at
    Questions about disclosure should be referred to the appropriate FOIA/Privacy Act contact in your
    Frank M. Torti, M.D., MPH
    Acting Commissioner of Food and Drugs

  6. JiM

    In answer to your question.


    This sort of things come to public light only once in a while. (More occurs that doesn't reach the major news outlets.) Grassley definitely knows about all of them, and in many cases FDA knows that Grassley has been told. When they do know they harasss and fire the reviewers, and believe me if you've been let go from FDA you're career is over, there's absolutely nowhere in industry or in academia you can go.

    Grassley may or may not make noise in public but that's all he can do. Unless he has the entire Finance Committee supporting him (highly unlikely since so many are receiving drug co money) and the Committee hauls FDA officials down and then actually does something FDA officials know nothing is going to happen.

    In fact even when officials are hauled down to capital hill they just promise it won't happen again so until people are fired and go to jail as suggested in Grassley's letter nobody at FDA is going to do anything different.

    We've seen this happen again and again. Woodcock has even gone to the press and complained that congressional oversight is stressing the staff (meaning herself as she, Von E and a few others directly under her were the ones under scrutiny that time).

    FDA management then just turns around and harasses the reviewers even more. This is how it works throughout government.

    Other reviewers see the whistleblower slowly twisting in the wind and either leave, just shut up and wait for retirement, or jump on the bandwagon with FDA management. Why the people who turn in the whistleblower or help set them up for elimination are rewarded and promoted and evenone inside knows this.

    Pharma as taken over the FDA and they know Grassley is simply blowing smoke.

    Been there.

  7. What I believe Anonymous is saying is that, despite information sent to Senator Grassley (and others), to show and prove serious issues, seldom is anything done when those issues are exposed without being backed by legal actions that are not so easily brought.
    I have written Grassley myself (a few times) and nothing was done to address a very obvious problem. Even when there was FDA personnel that concurred with the information.
    Recently the Senate Finance Committee did raise all of the right questions. I want to believe that the reason for those questions is not just to run interference to prevent future problems for FDA, as vital as prevention of further known issues are, but more to protect consumers. That is nearly impossible to believe when they know something was wrong, illegal, dangerous, and nothing has been done about it.
    When nothing is done to address the issues of the moment, no matter how many ways you prove there was inappropriate activity or bad choices that caused damages, consumers are brushed aside, info received- we got what we need now. No action against those involved in causing damages. Damages backed up with plenty of documentation.

    Which brings us full circle as FDA appears to be trying to make it more difficult to expose bad practices within the agency. No one pays a price for harming consumers if FDA makes bad or rash decisions.

    Grassley is doing the right thing with his letter attempting to allow FDA employees to come forth. When they do come forth though- what then? What action is taken? None that I have seen. It seems the only action is to attempt to allow Congress to continue to be notified. So what?

    It is sort of like having a job and getting fired for pointing out a hazard that is costly to repair. You did the right thing. The boss doesn't want to deal with yet another issue. Poof, you're gone. The guy replacing you gets to enjoy a safer work environment.

    Did I read you right, Anonymous?

  8. It IS having a job and getting fired for pointing out a hazard that is CHEAP to repair but will result in widespread death with likely no benefit.

    The guy replacing you has a less safe work environment because management is emboldened to increase corrupt activities.


  9. Obviously, this is corruption worthy of what we used to think happened only in those "other" countries.

  10. I am beginning to think that anyone anywhere who is on any prescription drug show solidarity to the people in the FDA who want to fix the problem, and also show solidarity to Grassley and take a day or two break from the drugs.

    Furthermore, people everywhere should resist buying over the counter medication for a least one week. It is kind of like those gas station wars. "JUST SAY NO TO PRESCRIPTION DRUGS"

    Do not give them the money that they turn around and use to perpetrate crimes against the consumer.

    Consumers need to be more aware of what Grassley is doing and writ to him directly to support his efforts.

    He needs a lot of noise makers behind him.

    Yeah, looks like we are the "other" country....Funny how we keep thinking we can help people in other countries with their messes, when we have the messiest back yard of all....Why is our backyard the messiest? Because we have the intelligence to know what we are doing is wrong, yet we choose to do it anyway. That is unforgivable...

  11. I think what we are missing here is that Senator Grassley is of the legislative branch and it is his job to write law, not to enforce it. The Department of Justice has dropped the ball. They claim to be overwhelmed.
    On the other hand- if Grassley can warn against the illegality of this memo and go after so many doctors and professors who were paid to speak on behalf of drug companies- can the congressional committee which oversees FDA not move on illegal activities in the area of bad approvals? Anyone know?

    I'm with you. I will not take on a new medication. It's too much of a crap shoot when consumers are easily dismissed as having handled their medication wrong. It is too difficult to prove damages. Meanwhile the drug companies are aware they have caused damages and sit there and bitch about frivolous suits. They refuse to take responsibility for the harm they know they have caused.
    Make a profit and kill some trusting consumers off without liability as they attempt to discredit their market base- or make a profit and get a slap on the wrist. Either way, I'm done with them. I may die younger but I will not die of some remedy that was touted to improve my health. Maybe I won't die younger at all.

  12. The Head of the Nail Has Been Hit - It's all about the bucks

    Politics refuses to buck the buck, the FDA's management won't buck the boss nor will major media offend the provider of the bucks.
    So the bucks rule. But what goes around comes around.

    Changing the attitude of pharma can only be achieved by the power of the consumer’s bucks.

    How about a bumper sticker campaign? I know the creative folks here can come up with a short message that will drill right through all the smoke and alert the world to the fact that the pharma tail is wagging the dog.

    Boycott Prescription Drugs
    No more fraud!

  13. I disagree.

    FDA employees can go to jail if they release e-mails etc. even if they provide proof of felonies.

    FDA employees can provide this written proof of felonies to Grassley althuogh FDA management will intentionally mislead employees as Torti just did.

    These felonies can include murder because we know when the drugs won't work even in spite of the approved indication and yet will kill numerous people. It can even include genocide because we know which groups have certain genetics that will increase the likelihood that the they will be killed if they take a drug that won't work. However when FDA management knows you've provided the data you're gone and you've got to worry about both your's and your family's safety. Grassley however could release those documents if he wanted to because he has immunity.

    Is it any wonder that Torti thinks Grassley's a joke.

    You can't boycott prescription drugs even if they are unsafe. For it may be more dangerous to go on and off and on. Or just off for some people. FDA reviewers can give you the information if it's worth the risk to take and how to get off them safely if it isn't however it's illegal for them to tell you.

    Been there.

  14. Anon, Of course you are right about the Boycott. Some other form of protest/bumper sticker would be better. Maybe just more of a statement.

    Pharmaceutical Industry
    No more fraud!

  15. Actually, Anon isn't right. There are many prescription drugs that can be stopped, must be stopped.

    There are many over the counter drugs that can be stopped.

    Each consumer only has to google the net to find out which ones are the right one to stop and how to go about it.

    Buying drugs these days is like paying a "stupid tax".....

  16. Hate to tell you but the information often isn't on the net. Even if it were do really think a boycott is going to work. Give me a break.

  17. Any thoughts on what might work in raising the awareness of the public concerning the atrocious behavior of some of the folks in the pharmaceutical world?

  18. It is not only pharma. Others such as drug wholesalers, pharmacies, PBMs and insurance companies all profit from drugs.

    Insurance companies and PBMs can profit twice...once when the policyholder gets the dispense, and a second time when the policyholder sues, wins damages and the insurer/PBM sues the policyholder to collect previously paid claim amounts (think Vioxx).

  19. Well, there is only way to find out if a boycott works - do it....

    Stay tuned, a see a full scale boycott looming on the horizons...

    Power to the people!

  20. "nor will major media offend the provider of the bucks".

    How can people be informed if the media refuses to offend those who purchase ad time/space? Has the power of the press sold it's soul? Integrity vs. viability?

    The press needs to be able to rely on the public to exist. The public needs to be able to depend on the press for good and accurate information. Is it any wonder that the news industry finds itself in such a bad situation if they can not, will not, report on such things because of needed ad dollars. When did money start dictating reporting practices?

    Journalism 101- do not offend your advertizers, ever!?

    Ed may not be God but he has integrity. Not so sure the journalism business, overall, can recover unless it finds a moral compass again. I heard there may be bailouts for the news industry but, you can't fix the auto industry if people can't afford cars- anymore than you can fix journalism if people will not buy skewed and deluted reporting- anymore than you can sell drugs if you lose consumer confidence.

    Business 101- the customer is always right.

  21. I guess that is what this is all about - it is about finding our moral compass again.

    We've lost our way, we've all lost our souls - we ARE lost souls...

    In thinking we've outsmarted the consumer, we've outsmarted ourselves. We laid a mine field of obstacles to the truth....

    "What a wicked web we weave, when OURSELVES we choose to deceive....."

  22. Good advice from an old favorite:

    "Don't interfere with anything in the Constitution. That must be maintained, for it is the only safeguard of our liberties. And not to Democrats alone do I make this appeal, but to all who love these great and true principles."

    -Abraham Lincoln, August 27, 1856, Speech at Kalamazoo, Michigan

  23. Dr. Joshua Sharfstein has arrived.

  24. And Torti is departing. Will be interesting to see how JS and MH handle this.

  25. I was a whistleblower at DHHS, not FDA and received an agency imposed gag order and was told if I responded to a congressional inquiry I would be fired. I was threatened over and over again as I reported violations of gross fraud, gross waste, gross abuse, gross mismanagement and an abuse of public health and safety to the DHHS Office of the Inspector General. I went to OSC, MSPB and EEOC which were no help with 1st amendment or equal protection rights. When I filed at MSPB that my 5th amendment due process of law rights had been violated...I was fired 4 days later! Now I am fighting my way back to tell the truth about DHHS, and how MSPB and OSC stood idly by was I was tortured for a year. I have evidence of DHHS lawyers advising management on how to violate the Whistleblower and No Fear Acts and EEOC law. Part of this fiasco at DHHS belongs to the NTEU who agreed to horrible collective bargaining that only allows the employee to refuse to obey an order if their (not the public) health or safety is in jeopardy. I make the argument that to go along with fraud and dangers to public health make you are complicit in violations of law and part of a conspiracy. DHHS needs major reform and it is no small wonder the country is in a health care crisis. Thank you Senator Grassley.


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