Plan Would Enhance Communication of Potential Drug Shortages, Expedite Reviews to Avoid Shortages

Bennet Part of Bipartisan Group That Negotiated Drug Shortage Component of FDA Reauthorization

Colorado U.S. Senator Michael Bennet has joined a bipartisan group of Senators to unveil a plan to protect Colorado consumers and families by helping to avoid critical prescription drug shortages, like the ones we have seen across the country.

The Senators released a discussion draft of a bill that would enhance the ability of the Food and Drug Administration (FDA) to address and avoid drug shortages. The plan calls for enhanced notification of potential drug shortages or disruptions and gives FDA authority to expedite reviews of drugs to mitigate the effects of a shortage. The discussion draft is one component of the FDA reauthorization that is expected to move through Congress this year.

“Coloradans want a drug supply that is both safe and readily available to patients,” said Bennet. “This plan would ensure FDA prioritizes drug shortage concerns, enhance FDA’s knowledge of potential drug shortages before they happen and give them the tools to address and mitigate them when they arise. It takes an important step toward ensuring that patients have the life-saving or life-sustaining prescription drugs they need.”

Specifically, the plan would:

• Require all manufacturers of a life-supporting, life-sustaining, or debilitating-disease preventing drug to notify HHS of an interruption or discontinuance of the manufacture of the drug that could lead to a meaningful disruption in the supply of that drug to the United States;
• Grant the Department of Health and Human Services (HHS), if there will be a drug shortage of a life-supporting, life-sustaining, or debilitating-disease preventing drug, the authority to:
  • expedite the reviews of certain new drug applications where that new drug could help mitigate or prevent the shortage
  • expedite the inspection of an establishment that could help prevent the shortage;
• Require HHS to establish a Task Force that will mitigate and prevent drug shortages through interagency, intraagency, expert, and stakeholder coordination and planning;
• Require HHS to conduct an internal review all of the regulations, policies, and guidelines issued under the Food, Drug and Cosmetic Act to determine if they need to be modified or streamlined to reduce or prevent shortages; and
• Require a report reviewing any findings that drug shortages have led market participants to stockpile or increase prices of the affected drugs and any economic factors that create or exacerbate these actions.

The United States is currently facing critical drug shortages that can hurt patients who need treatment the most. Many life-saving cancer and anesthesia treatments are in short supply nationwide, forcing doctors to choose between prescribing prohibitively expensive drugs or drugs from nontraditional sources that may supply less effective and potentially unsafe products. In Colorado Springs, drug shortages have forced doctors at Penrose-St. Francis Hospital to delay therapy for some leukemia patients and to substitute less effective antibiotic medications for those that are in short supply.

Recently, Premier healthcare alliance found that when there is a massive drug shortage, providers are faced with price gouging attempts by “gray market” vendors of offered markups of drugs on average 6.5 times - and as much as 45 times - their normal market price. The gray market includes the selling of drugs through unofficial or unauthorized supply channels where providers cannot always verify the source of a drug. The Premier report included data on 1,745 unsolicited gray market offers with the highest mark-ups seen for critical care sedation and surgery, emergency care, chemotherapy, and fighting infectious disease.

Bennet has long been calling for reforms to give the FDA more authority to address and prevent critical drug shortages. In December, the FDA expressed support for Bennet’s call for a universal system to monitor pharmaceutical drugs through the supply and distribution chains to help avoid drug shortages.

In addition to Bennet, the bipartisan working group includes Senators Tom Harkin (D-IA), Mike Enzi (R-WY), Lamar Alexander (R-TN), Richard Blumenthal (D-CT), Richard Burr (R-NC), Bob Casey (D-PA), Al Franken (D-MN), Kay Hagan (D-NC), Johnny Isakson (R-GA), Mark Kirk (R-IL), Barbara Mikulski (D-MD) and Pat Roberts (R-KS).

Click here to read the discussion draft.