Press Release

PhRMA Statement on Sustainability & Manufacturing Process

PhRMA May 1, 2013

Washington, D.C. (April 23, 2009) — Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson issued the following statement today in response to recent media attention surrounding pharmaceutical ingredients discharged by manufacturing facilities:

“Recent public concern about media reports of traces of medicines in the water deserves some clarification of the role America’s pharmaceutical companies play in fostering sustainable manufacturing practices as part of their goal of delivering new medicines to patients.

“America’s pharmaceutical companies comply with environmental regulations as part of their New Drug Applications and manufacturing processes. As part of that process, pharmaceutical companies evaluate the potential impact of its compounds on the environment. Extensive data about the potential effects of a compound must be researched and generated as part of those environmental assessments in the US. This information is considered by the manufacturing plant in determining what, if any, compound specific treatment is needed prior to effluent discharge.

“Wastewater generated by pharmaceutical manufacturing is treated in wastewater treatment systems, either at the manufacturing facility or at a municipal treatment plant, that are permitted in compliance with the National Pollutant Discharge Elimination System. Decisions regarding the need for compound specific treatment are based on risk assessments that consider the specific properties of the pharmaceutical ingredients, health and toxicology effects studies, the wastewater treatment plan the effluent is discharged to, the receiving waters, and other factors.

“Additionally, America’s pharmaceutical industry is heavily invested in integrating ‘green chemistry’ principles into the design, development and manufacturing of medicines to reduce or eliminate environmental impact.

“In a recent Associated Press story, it was alleged that more than 271 million pounds of compounds are released into waterways per year. It was argued that the majority of these compounds were pharmaceutical ingredients; however, the two most prominent substances mentioned in a recent Associated Press story are primarily industrial chemicals and their use as pharmaceutical is miniscule by comparison. Two chemicals -- hydrogen peroxide and phenol -- account for more than 92% of the alleged 271 million pounds of compounds released, and these compounds are used primarily as bulk industrial chemicals rather than human pharmaceutical products.

“A recent story written by the Associated Press suggested that compounds are discharged by manufacturing facilities in dangerous amounts, but failed to note the absence of adverse health effects found at the trace levels detected. Only trace amounts of pharmaceuticals are found in the environment and scientific studies conducted to date have not indicated any appreciable risk to human health. The small amounts of pharmaceuticals being measured in surface waters come primarily from patient use. Trace amounts of medicines pass through the human body without being metabolized completely and make their way to surface waters through the municipal wastewater treatment system. The amounts detected in untreated water used for drinking have been very small – the equivalent of a single cube of sugar dissolved in two and a half million gallons of water (about four Olympic size swimming pools).

“Questions about the safety of drinking water have been addressed over several years by authors from the pharmaceutical industry, academia, government and the non-government sector. To date, no published investigation has found that exposure to these detectable residues poses a risk to human health.

“America’s pharmaceutical companies work closely with various local, state, and federal agencies to understand and reduce the environmental impact of the research and manufacturing process of new medicines. FDA regulations established under the National Environmental Policy Act consider the potential impact of pharmaceuticals on the environment. The Environmental Assessments submitted by pharmaceutical companies as part of their New Drug Applications have shown that pharmaceuticals have had minimal adverse impact on the environment. In the process of manufacturing new medicines, a facility must comply with state guidelines on waste management as well as local water board and municipality regulations that control pre-treatment and testing practices of wastewater streams. This process of environmental testing and regulation prior to manufacture and approval of a new medicine evidence America’s pharmaceutical company’s commitment to patient safety and sustainability practices.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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