Senate Bill for Drug Shortages Does Not Go Far Enough

May 30, 2012 — In an overwhelming 96 to 1 vote last week, the US Senate approved a bill that, among other things, will help to prevent shortages of lifesaving drugs.

However, some experts believe that the bill does not go far enough, even though they see it as an important first step.

The bipartisan Food and Drug Administration Safety and Innovation Act (SB-3187) will require drug manufacturers to notify the US Food and Drug Administration (FDA) as soon as they anticipate interruptions in drug production, and 6 months in advance if a product will be discontinued.

The bill also authorizes $6.4 billion in user fees over the next 5 years for manufacturers seeking the approval of branded and generic drugs, medical devices, and biotechnology products.

It is expected that the House of Representatives will pass a similar bill soon — the FDA Reform Act (HR-5651).

The American Society of Hematology (ASH) notes that the Senate bill exempts biologics from all provisions, and is particularly concerned that products derived from human plasma proteins and recombinant products replacing human tissue are specifically exempted from the early-reporting mandate in the legislation.

"It is my understanding that the House bill covers biologics, but not plasma products," said Armand Keating, MD, president of ASH. "We are really hoping to work with the House version to see if we can get plasma products included."

There have been shortages of plasma products in the past that have been quite serious, Dr. Keating explained.

It is unclear why these classes of agents have been excluded from the bills. One argument is that with the plasma products, "there is a perception that in a sense they are already covered," he said. "But if you look at this in detail, what is covered is notification of production, not shortages. So it doesn't address the issues adequately."

Information about production must be provided for only about 5 of the 25 plasma products, he added. "Thus, it is really a compounding of inadequate reporting."

Spike in Drug Shortages

Drug shortages are not new, but in previous years they were largely intermittent and temporary. Recently, however, the situation has reached crisis proportions. According to the FDA, the number of drugs deemed to be in short supply nearly tripled — from 61 in 2005 to 178 in 2010. In 2011, there were roughly 200 shortages reported. Many of the products in short supply are generics, primarily sterile injectables, and include cancer medications, anesthetics, and antibiotics.

As previously reported by Medscape Medical News, the FDA announced a series of steps earlier this year in response to the critical shortage of methotrexate and doxorubicin (Doxil). For doxorubicin, the FDA announced that there would be temporary importation of a replacement drug. For methotrexate, a new manufacturer of the preservative-free formulation of methotrexate was approved.

More Enforcement Needed

"The fundamental aim of this effort is to improve and protect patient care by making sure we don't run out of drugs, or that we have a good warning that these shortages are coming," said Lawrence A. Solberg Jr., MD, PhD, 2011 chair of the ASH Committee on Practice, and professor of medicine at the Mayo Clinic in Jacksonville, Florida. "It doesn't strike us as logical that if we are trying to protect patients, we just omit this class of drugs."

"As a society," Dr. Solberg told Medscape Medical News, "we are very concerned about these biologics and human plasma proteins, and we strongly feel that the reporting process built into these bills should be linked to some sort of civil penalty or enforcement mechanism."

The American Society of Clinical Oncology (ASCO) agrees. In a statement, ASCO president Michael P. Link, MD, noted that an "essential element to averting shortages is to require drug manufacturers to notify the FDA 6 months in advance of market withdrawals or manufacturing interruptions."

Although they are pleased that the legislation includes this mandate, "it must be bolstered by fines or similar penalties to ensure that manufacturers comply," he added. "ASCO hopes that this enforcement mechanism will be added when the bill is in conference committee."

Dr. Solberg emphasized that they are pleased that this legislation is underway and that policy members are engaged. "We appreciate all of the progress that has been made. But we represent these patients, we take care of them, and we need to speak up for them," he said.