Senate Bill 959 Part 1

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Compounding Pharmacies and the Government

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In this podcast, Brett Newcomb and I are talking about Senate Bill 959, a bill before the Senate Health Education Labor and Pensions committee, chaired by Senator Tom Harkin. This is a fifty five page bill that attempts to redefine the way the government regulates Compounding Pharmacies. This is a bipartisan bill which was brought to this committee after the disastrous experience with a single compounding pharmacy last year.

We believe that there are many excellent points in this bill, and the modifications of regulations regarding safety and supervision to become more stringent, are good things. However we are concerned that upon a more close reading of some of the provisions, something that is not a good solution to this problem is also being added. This bill includes provisions to allow the Secretary of Health and Human Services to create a list of medicines that compounding pharmacies cannot make. What concerns us about this is that there are no provisions or requirements for the Secretary to follow any particular set of guidelines as the list is created. There is no requirement to establish panels to make recommendations, there is no requirement that pre- existing established ways of operation for compounding pharmacies is included in the bill. Compounding pharmacies have been an essential part of the mix of modern medicine for many years. They play a critical role in the provision of medicines, often called orphan drugs that the major pharmaceuticals do not make because there is no profit in them. They also provide generic productions of drugs once the patent has expired that creates price competition for the major pharma establishments. This competition is a good thing.

In today’s podcast Brett and I talk about the general operation of government regulatory agencies that have a hand in the medical arena. The HHS, the DEA, the FDA and others. All have regulatory power and authority. Yet they often (if ever) do not speak with each other to coordinate an approach to a problem. We give examples today of actions taken by the FDA to send the message to the consuming public and to doctors that the FDA thinks too many doctors prescribe ADD medicines. As a result of their thought that to many doctors prescribe this medicine, they have restricted manufacturing. We find this to be frustrating, arrogant, and reprehensible as well as misguided. Another example we cover in the podcast is an example of a letter I received at my office from the DEA about the procedure for prescribing and obtaining testosterone pellets for my patients. Listen to the podcast for the details, but the point we want to make is that the governmental regulation is often similar to a multi-headed hydra that works without coordination and consistency, with each authority trying to do its job as it understands it, but causing havoc in the lives of patients and in the practices of physicians trying to take care of them.

We want you to be informed consumers and we want you to be activist citizens. Contact your senator and or Senator Harkin to let them know that you do not want them to support Senate Bill 959 as it is currently written. Thank you.