Policy Issues


The New England Biotech Association (NEBA) supports public policies that promote innovation and encourage economic development within the biotechnology and biopharmaceutical industry in New England.

NEBA encourages legislators and other key officials at the local, state, and federal level to adopt policies that:

  • Assure that patients have continued and open access to life-improving breakthrough biotechnology and biopharmaceutical medicines
  • Provide tax incentives for research and development, creation of high-skilled jobs, and the delivery of new and innovative therapies to patients for unmet medical needs
  • Increase collaboration and technology transfer between the biotechnology industry and academic institutions
  • Promote economic development and job growth in the biotechnology and life-science sector via expedited permitting, zoning changes, and other targeted incentives
  • Ensure continued innovation and investment in the biotech sector in New England by protecting patents and intellectual property
  • Support a strong educational foundation for the biotechnology industry in New England with increased resources and focus on quality math and science education
  • Create a qualified, sustainable employment base for biotechnology companies in New England through comprehensive job training and workforce development programs

The New England Biotech Association urges policy makers in New England to oppose measures harmful to the biotech industry such as: price controls of breakthrough medicines; onerous restrictions on educational & marketing practices of biotechnology companies; and risky importation of medicines not regulated and approved by the FDA.

2015/2016 Public Policy Priorities

 

Biosimilars

  • Patient safety and enhanced access to biological medicines are key.
  • For regulatory purposes, treating biosimilars like generic "small molecule" medicines is inappropriate because biosimilars are not the same as their reference biologics. Unlike "generics," biosimilars are highly similar but not equivalent to the original medicine.
  • To ensure patient safety with regard to such medical concerns as adverse events/reactions, it is important that biosimilars are named and otherwise identified in such a way as to clearly distinguish them from their reference biologics.
  • We look forward to working with state legislatures, state regulatory agencies, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on outstanding biosimilar-related issues, including interchangeability, labeling, naming and appropriate Healthcare Common Procedure Coding Systems (HCPCS) codes.

Medicine Pricing "Transparency"

  • Legislative efforts to date to bring more pricing "transparency" have been misguided and counterproductive. Were they to be successful, they would reduce research and development and slow the pace of bringing new medicines to patients. A focus on medicine manufacturing costs, while ignoring the huge costs of research, development and clinical trials, grossly underestimates the true cost of bringing a medicine from laboratory to pharmacy shelves. FDA approved medicines are priced, as well, to cover the vast majority of new medicine research and development efforts that are unsuccessful.
  • Compared with other components and costs in our healthcare system, such as many hospital services, medicine pricing is already remarkably transparent.
  • Although the seemingly high cost of a few innovative medicines attracts much attention, medicines represent only 10% of American health care costs, a figure that has held strikingly steady, if not declined, in the past 50 years. Further, the fact that seemingly costly innovative new medicines replace more costly hospitalizations, surgeries and the like is overlooked.
  • Patient access is of paramount importance. Medicine-price transparency legislation does nothing to rein in the sky high co-pays of insurance company "specialty tiers" that often have the effect of making innovative, life-saving, new medicines unavailable to patients.

Take back/Pharmaceuticals in the Environment

  • We support efforts to help consumers safely dispose of unwanted medicines. However, there is no rationale for mandating new, costly and redundant disposal options when the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the Environmental Protection Agency (EPA), the Office of National Drug Control Policy (ONDCP) and the U.S. Department of Fish and Wildlife (USFW) provide guidance for in-home disposal in conjunction with voluntary national, state and local take-back programs.
  • Safe medicine disposal programs help prevent disposal in an environmentally unfriendly manner. Because of the way our bodies metabolize the medicine we take, some trace amounts of pharmaceuticals may still be found in surface waters. But it should be understood that the quantity of pharmaceuticals in the water supply is exceedingly small - equivalent to a single sugar cube dissolved in more than two million gallons of water. That's the size of four Olympic-size swimming pools. Peer-reviewed studies indicate little risk to human health posed by such insignificant amounts. There have been no published studies to date showing any harm to people from these amounts.