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State's "Right to Try" Legislation Hangs Drug and Device Manufacturers Out to Dry.

January 20, 2015 | Bryan Mouber
UPDATE   In response to concerns from patients and physicians that the process for gaining access to investigational drugs was too difficult, the FDA introduced a simplified application form for use in requesting permission directly from the FDA for permission to use an investigational drug.

The draft form and recommendation from the FDA may be viewed here.

Kansas has joined a short[1], but growing, list of states introducing legislation purporting to give terminally ill patients the option to try drug treatments not yet approved by the FDA, but which have passed Phase One FDA testing. However, the legislation does not incentivize any manufacturer to provide such drugs and in fact potentially exposes a manufacturer who does provide access to additional risk of lawsuits.

Three Kansas representatives sponsored House Bill 2004, titled “Kansas Right to Try,[2]” to be taken up by the full legislature in the upcoming 2015 session. The Kansas bill is based on, and is substantially similar to, model legislation drafted by the Goldwater Institute.[3] The very laudable goal of the statute is to help terminally ill patients gain access to any new investigational drugs they may wish to take. 

Unfortunately, no state law, including this bill, can accomplish that goal.

Federal law preempts state law on the issue

First and foremost, federal law regulating the use of prescription drugs occupies the field on this issue and prevents states from creating new regulations regarding access to unapproved drugs undergoing FDA approval. The Federal Food, Drug, and Cosmetic Act states that:

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application … is effective with respect to such drug.

21 U.S.C.A. § 355(a).

The Kansas statute does not encourage or allow the use of investigational drugs, but instead explicitly attempts to insert Kansas state law in the middle of the FDA approval process by purporting to allow a doctor to prescribe and a drug company to distribute an investigational drug undergoing FDA testing. In this case, the FDA has the clear authority to oversee testing and approval of drugs, especially in the case where a drug company has already voluntarily applied to the FDA for approval. Thus, while state law might give the patient the right to try, only federal law can grant a drug company the right to provide.

Doctors and drug companies will still face a threat of liability

Nothing in the model legislation, the Kansas bill, or the legislation passed in other states absolves drug companies[4]  from liability due to the patient’s use of an investigational drug. The laws, to varying degrees, require a patient’s informed consent, but given that the patient is terminally ill, the signed consent form is arguably coercive. (“If you don’t sign this release, you’re sure to die” isn’t exactly a situation calling for the unfettered exercise of equal bargaining power.[5]) Furthermore, none of the laws expressly allow the patient to sign away the patient’s potential claims against the drug sponsor or the physician who prescribes the investigational drug, nor do they require or permit the waiver of claims that might be asserted by the patient’s heirs.  Such provisions would have given more teeth to the informed consent and given drug sponsors and physicians some assurances that the provision of investigational drugs would not expose them to potential liability.

The easier way to eliminate liability, at least under state law theories, would be for the statute itself to provide in no uncertain terms that any patient who chooses to take an investigational drug may not bring a cause of action against his or her physician or the drug company supplying the drug. Ideally, such statute would likewise foreclose claims by heirs and others who might claim through the patient. None of the statues do this, and in fact the Kansas statue makes the liability situation murkier.

The Kansas legislation states that, “Nothing…shall be construed as creating a private cause of action against a manufacturer…or any other person or entity…except when such injury results from failure to exercise reasonable care.” HB 2004, §7. This is problematic, because, first, the legislation does not need to “create” a cause of action. Plenty of causes of action already exist, and plaintiffs bring them every day against both doctors and drug manufacturers. The statute does nothing to limit the liability of a doctor or drug manufacturer who takes the risk of prescribing and providing a drug not yet approved by the FDA. Second, the statute by its very language, creates a new cause of action for violation of the statute for failure to “exercise reasonable care.” It is unclear how a court might define how to “exercise reasonable care” in prescribing a drug that the federal government has not yet determined to be safe for humans, so the risk to a doctor or drug manufacturer who relies upon this Kansas statute seems high.

Thus, while doctors and drug manufacturers may be sympathetic to the plight of terminally ill patients, they are not likely to provide investigational drugs under a statute requiring them to accept unknown and potentially unlimited liability for doing so.

Patients, too, may be reluctant to try unapproved new drugs

Some patients simply may not wish to try investigational drugs, but even those that are eager to do so may balk or simply not qualify for some of the law’s provisions. First, no patient in a hospital or surgical center can use investigational drugs. HB 2004, §3a2. The Kansas House Bill recognizes that a hospital’s pharmacy, when dispensing medication, is governed by the federal regulations of The Centers for Medicare and Medicaid Services, which would, based on federal preemption principles, prevent a hospital from dispensing investigational drugs.

Second, health insurance may not pay for the cost of the drug and may not cover the cost of treating any side-effects of the drug. This bill expressly provides that an insurance company may deny coverage to any patient from the time the patient uses the drug until six months after the drug is stopped.  The bill creates an ambiguous  exception for pre-existing conditions. HB 2004, §4b2. Thus, it appears that, under the proposed Kansas legislation, a health insurer may deny coverage once the patient begins taking the drug, with the burden upon the insured to prove there is an exception to the statutory rule that would require the insurance company to pay. Third, the patient may lose other health benefits, including hospice care and in-home health care. Thus, it appears that the monetary risk to the patient is high under the proposed Kansas legislation.

Conclusion

While the Kansas House Bill appears to have good intentions, it seems likely that doctors will be reluctant to prescribe, drug and device manufacturers will be reluctant to provide, and patients themselves may be reluctant to request the administration of investigational drugs under the Kansas Right to Try law.

Author’s Note

Many other individuals and organizations have written insightful objective and opinion articles about the right to try issue, and their thoughts and research informed this author greatly in writing this article:

Drug and Device Law, “On Right to Try Legislation,” by James M. Beck October 23, 2014.

American Action Forum, “Right to Try,” by Brittany La Couture August 11, 2014.

BioCentury, “As right-to-try landscape expands in U.S., so does debate on laws’ effect,” by Steve Usdin, June 30, 2014.

GOP Lawmakers Pushing Right To Try To Expand Medical Care,” by John Celock, Dec 22, 2014.

U.S. News & World Report, “Seeking the Right to Try,” by Kimberly Leonard, Nov 18, 2014.

GOLDWATER INSTITUTE, “Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of Their Treatment,” by Christina Corieri, Feb 11, 2014.

Law Blog, “Expansion of Expanded Access? Federal Right to Try Legislation is Introduced,” by James C Shehan, Dec. 10, 2014.

Science-Based Medicine, “The Illusions of Right to Try laws,” by Jann Bellamy, March 6, 2014.

AZBio, “HCR 2005 – Right to Try Won’t Benefit Patients,” By Joan Koerber-Walker, March 24, 2014.


 

[1] Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§333.16221, 333.26451-26457; V.A.M.S. § 191.480. 

[2] The full text of the bill along with its history may be found here.

[3] The model legislation may be found here (created August 18, 2014) and here (dated Feb 11, 2014).

[4] Among the five states with Right to Try laws, only Louisiana law purports to provide blanket tort immunity to any doctor. La. R.S. §1300.385

[5] Drug and Device Law, “On Right to Try Legislation,” by James M. Beck October 23, 2014.

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The BSCR Kansas Law Blog examines significant developments, trends and changes in Kansas law on a broad range of topics that are of interest to Kansas practitioners and to businesses evaluating risks under Kansas law or managing litigation subject to Kansas law. Learn more about the editor, Bryan Mouber.

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