March 15, 2012

Congress Currently Writing Legislation to Address Drug Shortages

Holland & Knight Alert
Michael J. Werner

Congress is taking steps to respond to complaints from physicians, hospitals and patients about shortages of critical drugs. The latest congressional ideas to remedy this growing problem appeared in the long-awaited draft of FDA user fee legislation released by the U.S. House of Representatives Energy and Commerce Committee on March 13. Specifically, the legislation includes provisions designed to notify health providers and the public about drugs in shortage as well as to increase drug supplies and take other steps to prevent or alleviate shortages.

The legislation requires a manufacturer of a drug (brand or generic) to notify FDA of a discontinuance or interruption of the manufacture of the drug if it is likely to produce a shortage. The rule will apply to drugs that are:

  • life-supporting
  • life-sustaining
  • intended for use in the prevention of a debilitating disease or condition

The notification must occur at least six months prior to the discontinuance or interruption, or as soon as practicable. The bill does not define “life-supporting,” life-sustaining” or “intended for use in the prevention of a debilitating disease or condition” - but rather calls on FDA to promulgate regulations to define these terms.

Creation of a Public List

The bill also requires FDA to take steps to notify physicians and patients about these interruptions and to create a public drug shortage list. The list will contain the names of the drugs in shortage as well as other information including:

  • the name of the manufacturer of each drug
  • the reason for the shortage
  • the anticipated duration of the shortage

These disclosure and notification provisions are consistent with other legislation previously introduced in both the House (the “Preserving Access to Life-Saving Medications Act of 2011,” HR 2245, sponsored by Rep. DeGette (D-CO)) and Senate (S. 296, the “Preserving Access to Life-Saving Medications Act,” introduced by Sens. Klobuchar (D-MN) and Casey (D-PA)).

New Bill Is More Comprehensive

The new bill contains other provisions, however, and is more comprehensive. For example, it addresses shortages caused by U.S. government restrictions on the manufacture of drugs containing controlled substances. To produce these drugs, companies must get approval from the Drug Enforcement Agency (DEA) which regulates the quantity of these drugs on the market each year. Since these drugs sometimes become scarce, the bill requires the DEA to review manufacturer requests to increase production of these drugs within 30 days and remove production restrictions “as necessary to address a shortage.”

Moreover, the bill requires FDA to take steps to expedite the review of “major manufacturing changes” needed to prevent or alleviate a drug shortage. It also calls on the U.S. Government Accountability Office (GAO) to perform a study about the causes of drug shortages and develop additional recommendations regarding how to prevent or alleviate shortages.

More Bill Changes to Come

While this legislation represents the latest thinking in the House, it is likely to change before becoming final. In addition, other than S. 296 introduced last year, the Senate has been relatively quiet. Senator Hatch (R-UT) has said he is developing legislation that addresses shortages of certain drugs (sterile injectibles) by changing reimbursement rules for these products - particularly those developed by generic manufacturers - but no legislation has been drafted yet.

Thus, the situation is far from resolved. It is likely that the provisions in this House proposal will be modified over the next several weeks; the Senate is likely to develop new legislation as well. Therefore, companies and organizations with interests in these matters still have time to make their concerns known. This is particularly true if it becomes clear that the shortage is worsening, or if the proposed provisions will not prevent or alleviate shortages.

Congress is aiming to finish its work on this legislation by July. Whether they can take steps that will truly solve the drug shortage crisis by then is unclear.

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