1. Environmental Protection Agency and Food and Drug Administration: While I’m not asthmatic, I do follow continual government regulation. However, I’ve quite interested in how government regulations affect healthcare and the cost thereof for consumers. The new regulation is actually a planned amplification of previous regulations regarding clorofluorocarbon (CFC) use in metered-dose inhalers (MDI), where, as of 14 April 2010, seven more metered-dose inhalers will be phased out and replaced with hydrofloroalkanes (HFA) inhalers.
I do not expect this increased regulation to adversely affect me; however, the increased costs to consumers worries me. The affected products are especially used by lower-income individuals who must now pay increased prices for a MDI product currently under patent.
2. After the United States became party to the Montreal Protocol, it began phasing out and eliminating substances that purportedly deplete the ozone layer. Beginning in 1996, the US began prohibiting production and importation of CFCs unless for certain essential uses. Metered-dose inhalers (MDIs), used for treating asthma and chronic obstructive pulmonary diseases, are among the last to switch to ozone-safe alternatives.
MDIs use propellants to push medication out of inhalers, and the two most common propellants are CFCs and HFAs (hydrofloroalkanes). HFAs are considered ozone-safe and have already begun replacing products using CFCs. Both of these propellants, however, simply propel medication out of an inhaler.
The increased regulations from both the FDA and EPA consequently eliminate use of CFC-propelling MDIs, which are typically used in generic form. The purported ozone-safe alternative, HFAs, are largely used with medications currently under patent. Thus, MDI consumers are encouraged to discontinue using CFCs or finish using current CFCs and quickly transition to HFAs under direction of their physicians. These consumers will pay more for HFA MDIs because no generic form exists. Low-income consumers may qualify for payment assistance programs to afford higher healthcare costs with HFA MDIs.
3. With the following comment, I expect to accomplish two goals: one, to notify the FDA and EPA of the immediate increased financial costs placed on consumers, especially low-income consumers, previously used to paying generic medication prices for CFC MDIs, and, two, to speak out against government hypocrisy and over-regulation in the name of “environmentally-friendly” policies.
I would have submitted the following:
“While I understand and support the end-goal of the Montreal Protocol and the US government’s participation in said agreement, I believe there is a fine line between substantive policy and over-regulation. With respect to FDA and EPA regulation on CFC MDIs, I understand the scientific arguments against CFCs, but I fail to see the correlation between CFC MDI use and increased depletion of the ozone layer. True, CFCs in larger quantities, such as in certain pesticides, understandably have an important effect, especially when we consider the quantity released in the atmosphere. However, CFC MDIs emit virtually unnoticeable amounts into the air. Is the effect of CFC MDIs as hazardous to the environment as other major CFC products? My concern is that we are eliminating an affordable treatment for human asthma and other pulmonary ailments because the delivery mechanism has been linked (only linked) to ozone depletion. Merely being linked to an effect does not necessarily mean causation, or even correlation. If we are to increase healthcare costs to low-income customers, we should do so when the need is emergent. I would toot a different horn if the science on CFC MDIs showed direct results, but it doesn’t. The central justification for eliminating these products does not involve the level of CFC emitted by CFC MDIs. Thus, there is little way for consumers like me to understand whether or not our products are truly hurting the environment.
Furthermore, when the US government regulates business and consumers through agencies like the FDA and EPA, it often does so in a surprisingly hypocritical way. Case in point, science has repeatedly measured and shown the damage coal and gasoline-powered emissions cause to the atmosphere; however, neither agency seeks to eliminate these energy sources, even though their effect is clear. I understand the reasons for that hypocrisy, but I’m astounded that the US government would essentially ignore those energy sources’ effects but specifically target a small number of products that actually save lives.
Additionally, these new regulations will adversely affect MDI consumers and contribute to increased costs of healthcare. Currently, no generic alternative exists for HFA MDIs, which means that all MDI consumers must pay significantly more for treating their asthma or pulmonary ailments. While this may not matter to more affluent consumers, it does to low-income and fixed-income consumers. Those are also the two market segments that draw the most from healthcare and contribute to increased healthcare costs.
I am not opposed to providing alternatives and incentivizing changes from CFC to HFA MDIs, but I do oppose arbitrarily eliminating, even phasing out, cost-effective treatments. Phasing these products out will likely contribute little to “saving the environment” but will contribute directly and quickly to rising healthcare costs for individuals and, eventually, the country.
Before the US government regulates in such a manner, I believe that we should first be provided detailed and specific data into the environmental impact of CFC MDIs before further eliminating and phasing-out occurs. Even though the FDA provides estimates as to the expected environmental effect of CFC MDIs, it does not provide conclusive supporting evidence through measured data. Until such information is gathered and explicated, I urge the administration to reconsider the increased regulations until stronger proof is given.
4. Public comments must be made by or on 7 August 2007.
5. a.) According to the Freedom of Information Act amendment to the Administrative Procedure Act, I am entitled to receiving FDA rules, regulations, procedures, policies, and so forth if said information is not available publicly. By obtaining an FOIA request, I can request the information. In addition, I have access to three publications that detail US Code, statistics on US agencies, and updates of regulation changes, as part of the Federal Register Act. b.) The positivist theory would equate the FDA’s regulations as power because the FDA has been granted power; therefore, the new regulations are considered law. The idea that only what is law benefits the people is especially troubling in this instance. The idea of justice, that law must judge without regard to person and treat all with the same standard, provides further problems for these new regulations. Additionally, the notion of safety and certainty is also suspect in these regulations. Is it better to have the regulations to remove legal certainty or do these regulations cause too much harm? Lastly, natural law may also play a part in c.)
