Beveridge & Diamond
 

Pharmaceuticals Stewardship Legislation Introduced in Congress

Beveridge & Diamond, P.C., September 22, 2011

On September 15, 2011, Representative Slaughter (D, NY) introduced the Pharmaceutical Stewardship Act of 2011 (“The Act”) (H.R. 2939),1  which would create a national, producer-funded pharmaceuticals take-back program.  The Act would create a National Pharmaceutical Stewardship Organization and require manufacturers and brand owners of drugs marketed in the United States to participate in a certified pharmaceuticals stewardship program.  Product stewardship programs aim to provide convenient disposal alternatives that are protective of the environment and public health and safety.  Programs would need to be implemented within two years of the bill’s enactment.

Proposed Scope

The Act would impose stewardship requirements on manufacturers and brand owners of drugs marketed in the United States.  The term “manufacturer” is not defined, but the Act defines “brand owner” to mean “the holder of an approved application for the drug under section 505 of the Federal Food Drug and Cosmetic Act (21 U.S.C. 355).” 

The Act would apply to controlled and uncontrolled substances.  The term “drug” has the same meaning as in the Federal Food Drug and Cosmetic Act (FDCA),2 but the Act would exempt drugs for which a take-back program is already in effect under FDCA § 505-1. 

Creation of a National Pharmaceutical Stewardship Organization

The Act would establish the National Pharmaceutical Stewardship Organization (“Organization”), a private nonprofit corporation, and task the Organization with implementing a national pharmaceutical stewardship program.  The organization’s board of directors would include industry and public health representatives. 

National Certified Pharmaceutical Stewardship Programs

The Act would require the Organization to submit an application for a national product stewardship program to the U.S. Environmental Protection Agency (EPA).  EPA may certify the program if it meets criteria identified in the Act, including:

  • Participating manufacturers and brand owners fully pay the costs of the program; which would be allocated among manufacturers according to market share; 
  • The program is developed with public input;
  • The program accepts drugs that are delivered by individuals and are household wastes;
  • Collected drugs are incinerated in accordance with hazardous waste incineration requirements (EPA may approve alternative disposal technologies upon petition);
  • The program includes at least one collection site in every county of every state and every city with 10,000 or more people, or, where that is not feasible, the system provides prepaid mailing envelopes;
  • Controlled substances are collected and disposed of in a manner consistent with § 302(g) Controlled Substances Act (CSA); and
  • The program meets specific education and outreach requirements.

The Organization would be required to renew the program certification every four years.

Under the Act, drug manufacturers and brand owners may jointly or individually seek certification for a separate national pharmaceutical stewardship program that meets the criteria described above.  Certification for such programs would have to be renewed every three years. 

Certified programs would be required to submit annual reports to EPA, including information on the weight of drugs collected, any safety or security problems that occurred, the program’s total expenditures, and a description of packaging material recycling.  These reports would be made available to the public.  In addition, the Act would require certified programs to annually invite public comment on the services provided, share that information with EPA, and use the comments to inform program updates. 

Penalties, Program Suspension, and State and Local Laws

The Act authorizes civil penalties of up to $50,000 per day in instances where an obligated manufacturer or brand owner does not participate in a certified program or violates its obligations to contribute to a program’s costs. The Act would also authorize EPA to suspend the certification of any national program to protect the public from imminent danger.  States, tribes, and local governments could adopt more stringent drug disposal requirements. 

Commission & Report by the Comptroller General

The Act would require EPA to establish an interagency Commission on Drug Disposal and Its Public Safety, Public Health, and Environmental Impacts (“the Commission”).3 The Commission is tasked with development of a strategy to prevent drugs from entering the water supply and environment and to reduce diversion and the risk of abuse and accidental overdose.  The Commission would be required to submit a strategy to Congress within two years of the law’s enactment and annually thereafter.  The strategy must assess the risks and identify strategies for reducing risks associated with misuse of prescription drugs, address sources of contamination, and make recommendations on minimum environmental standards for disposing of drugs.  The strategy would be designed to inform EPA regulations and guidance on these issues. 

Finally, the Act would require the U.S. Comptroller General to submit a report to Congress on drugs and drug byproducts in surface and groundwater in the United States.  The report would be required to include recommendations for government actions to prevent entry of drugs and byproducts into the water supply and identify areas of additional research.

Existing Legal Landscape

The proposed law would enact the United States’ first mandatory producer responsibility program for pharmaceuticals.  The issue of pharmaceutical take-back has been considered at the state level and peripherally at the federal level for some time.

In October 2010, Congress enacted the Secure & Responsible Drug Disposal Act, amending § 302(g) of the Controlled Substances Act. The law allows an ultimate user to deliver a controlled substance to an authorized person for disposal in accordance with forthcoming regulations.4  Pub. L. 111-273 § 3(a), 124 Stat. 2859 (Oct. 12, 2010), amending 21 U.S.C. § 822(g).  While DEA has held a listening session, it has not yet proposed a rule identifying the specific requirements for delivery and disposal of controlled substances under § 302(g). 

Meanwhile, EPA proposed a rule in 2008 that would add hazardous pharmaceutical wastes to the Universal Waste Rule.  73 Fed. Reg. 73,520 (Dec. 2, 2008).  The Universal Waste Rule streamlines hazardous waste collection requirements for specified wastes.  EPA believes the designation of pharmaceuticals as universal wastes would remove barriers to the collection of pharmaceutical wastes and facilitate take-back programs.  Id.  EPA extended the comment period on the rule in 2009, but there has been no further action to date.  EPA has indicated that it has no projected date for finalizing the rule.

A number of states have engaged in pilot take-back programs (e.g., Maine, Iowa), but no state has imposed mandatory take-back obligations on manufacturers.  In 2011 several states considered, but did not pass, legislation that would have created mandatory producer take-back programs.  New York bills would have required all drug manufacturers to establish and implement take-back programs (AO 4651, AO 211/SO 0830).  In Washington, S.B. 5234/H.B. 1370 would have a manufacturer-funded and –managed product stewardship organization for the statewide collection and disposal of controlled and uncontrolled substances from residential sources.  The California Department of Resources Recycling and Recovery (CalRecycle) has recommended the state legislature enact legislation to create a privately financed pharmaceutical stewardship program. Recommendations for Home-Generated Pharmaceutical Collection Programs (Dec. 2010).  At the local level in California, the city of San Francisco considered an ordinance in May 2011 that would have imposed producer responsibility requirements on drug manufacturers that sell their products in the city.  Industry funded a pilot program in the city and the ordinance was reformulated to require informational materials at retail outlets.  Safe Drug Disposal Information Ordinance 85-11. 

In Canada, there is no federal program that imposes stewardship requirements for pharmaceuticals, but several provinces have addressed the issue.  British Columbia, Manitoba, and Ontario have enacted regulations that require manufacturer-financed take-back programs for pharmaceuticals.  All three provinces utilize a pharmaceutical stewardship organization to develop and implement the programs.

For more information, please contact Paul Hagen (202.789.6022, phagen@bdlaw.com), Jennifer Abdella (301.481.0811, jabdella@bdlaw.com), or Bina Reddy (202.789.6082, breddy@bdlaw.com).

For a printable PDF of this article, please click here.


1 A copy of the Act is available at www.govtrack.us/congress/bill.xpd?bill=h112-2939.  

2 The FDCA defines drugs as “(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.”  21 U.S.C. § 321(g)(1)

3 The Commission would consist of representatives from EPA, the Centers for Disease Control and Prevention, the National Institute of Environmental Health Sciences, the Drug Enforcement Administration, the Food and Drug Administration, Veterans Affairs, the Centers for Medicare and Medicaid Services, the National Drug Control Policy, and any other federal official with relevant expertise appointed or invited by EPA, individuals with expertise in public health, public safety, or the environment appointed by EPA, and state and local officials invited by EPA.  The Commission would terminate five years after enactment of the Pharmaceutical Stewardship Act. 

4 The Pharmaceutical Stewardship Act would require pharmaceutical stewardship organizations to manage controlled substances in a compliance with § 302(g). 

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