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Drug Safety Bill Puts Urgent Treatment in Jeopardy

We all remember the scenes in the film “Willy Wonka & the Chocolate Factory” where Gene Wilder nonchalantly warns, “Stop. Don’t,” as various characters try unknown products and experience unanticipated effects. Of course, each instance ends with predictably unfortunate results.

Congress’ attempt to regulate compounded medications poses a Wonka-esque scenario in which potentially well-intentioned legislation may have the unintentional side effect of harming patients and adding unnecessary costs to the health care system.

By nature, Congress is a reactionary institution. That’s how compounded medications — those specially prepared for a specific use and requiring techniques to avoid contamination from bacteria and other foreign materials — found their way into the crosshairs of the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions.

In 2012, a Massachusetts-based compounding pharmacy allegedly distributed contaminated medications that resulted in numerous cases of fungal meningitis and many deaths. To be clear, that was a tragedy worthy of close examination and, potentially, revised laws and regulations.

Legislation recently passed by the House to address this tragedy, the Drug Quality and Security Act, contains many improvements that would strengthen and enforce sterility standards that likely were not followed in the Massachusetts facility. But, as with many pieces of legislation, the devil is in the details, and the ultimate result may be that patient and physician access to certain essential compounded medications will be hampered or eliminated.

A critical flaw in the Drug Quality and Security Act is the House’s decision to exclude drugs that undergo “repackaging,” a type of compounding where different drug components are not actually mixed but rather an existing medication is divided up into new containers or delivery devices.

However, repackaged drugs require identical sterility techniques and standards as other types of compounded drugs covered by the pending legislation, so it seems inconsistent for Congress to treat them differently.

If that weren’t enough, such an exclusion would fail to bestow on repackaged medications a key protection negotiated with key stakeholders for compounded medications that remain covered by the bill: the fact that a patient-specific prescription is not required in advance for urgent uses.

Put simply, requiring a patient-specific prescription before a drug can actually be shipped — possibly from another state — could cause delays that would hinder treatment for many diseases, particularly those of the eye.

One particular repackaged drug — Avastin — is used to treat the rapidly blinding disease “wet” age-related macular degeneration. Avastin is one of two drugs used to treat this disease and costs about $50 per dose. The other is Lucentis, which does not require compounding or repackaging, but is about 40 times more expensive at $2,000 per dose.

Creating obstacles to getting Avastin would carry significant implications for Medicare. For example, in 2008 that program paid for 480,000 Avastin injections and 337,000 Lucentis injections. The total price for taxpayers was $20 million for Avastin and $537 million for Lucentis. If only Lucentis were used, the cost to taxpayers would rise to about $1.3 billion.

Furthermore, use of Avastin results in a lower cost for the patients themselves, who pay an average of $11 per Avastin treatment compared with $400 for Lucentis. For a typical series of six treatments, Lucentis has a personal cost of $2,400, while Avastin is just $66.

Faced with the choice of paying exponentially more or waiting, seniors living on a fixed income might make health care decisions based on their immediate financial needs rather than what’s best for their long-term health, in this case forgoing treatment with Lucentis (likely available immediately) until Avastin can be obtained. This delay — which could exist solely because the Drug Quality and Security Act fails to prevent it — might lower seniors’ ability to preserve their vision.

All of this is avoided by treating all compounded drugs equally. So, before the Senate is tempted to act on impulse and pass the House version of the legislation, it might well recall Wonka’s warning to young Violet Beauregarde as she started chewing a piece of gum that ended up having the unanticipated “side effect” of turning her into a giant blueberry:

“Oh! I wouldn’t do that. I really wouldn’t.”

Dr. Craig H. Kliger is executive vice president of the California Academy of Eye Physicians and Surgeons.

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