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March 14, 2013

Public Citizen to FDA: Lax Oversight of ‘Compounding Pharmacies’ Contributes to Drug Shortages

Stronger FDA Enforcement Would Create Incentives for Mainstream Drug Companies to Produce More, Safer Medications

WASHINGTON, D.C. – Strengthened enforcement over compounding pharmacies that act as drug manufacturers would help alleviate drug shortages by creating incentives for mainstream drug manufacturers to produce high-quality, Food and Drug Administration (FDA)-approved medication, Public Citizen said today in comments submitted to the FDA’s Drug Shortages Task Force.

The FDA has been lax in enforcing existing laws against companies calling themselves compounding pharmacies, allowing them to mass produce standardized drugs without seeking approval from the FDA. These “pharmacies,” which are really drug manufacturers in disguise, are permitted to flood the market with cheaply produced, substandard drugs, Public Citizen said. This practice discourages mainstream manufacturers from investing in the more expensive practice of producing safe, regulated and FDA-approved medications to meet consumer needs and prevent drug shortages.

“When the FDA allows companies calling themselves compounding pharmacies to manufacture drugs without meeting approval and quality control requirements, of course they will be able to undersell the FDA-approved product,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “This means the availability of high-quality, safe treatment options dwindles, leaving patients at the mercy of a poorly regulated industry.”

Public Citizen’s comments were in response to the task force’s request for public input about how best to address the ongoing national problem of drug shortages.

Compounding pharmacies can take advantage of the FDA’s lax regulatory environment by advertising themselves as suppliers when FDA-approved products are unavailable or in short supply. For example, the compounding pharmacy PharMEDium keeps an updated list on its website of the most recent drug shortages and encourages purchasers to contact PharMEDium customer service for additional information and assistance.

Hospitals, doctors and patients seeking drugs in times of shortage — or at other times — have no way to compare the quality of FDA-approved products with substandard products manufactured by compounding pharmacies. Companies like PharMEDium often announce that they comply with strict quality standards and in some cases even register themselves with the FDA. It is typically not evident from promotional materials that the advertised products are not FDA-approved, because compounding pharmacies are not required to label their products with a statement to that effect.

While FDA officials have insisted since last year’s compounding-linked fungal meningitis outbreak that the agency lacks adequate authority to regulate compounding pharmacies, the FDA inspects many firms representing themselves as such, in some cases repeatedly. Through these inspections and other reports, the agency learns of cases in which particular companies violate federal standards necessary to ensure drug quality or market products that are not FDA-approved.

This failure to comply with federal standards can have deadly consequences that are not apparent to doctors and patients. For example, FDA inspectors repeatedly reported sterility issues after visiting PharMEDium’s facilities eight times between 2004 and 2013. The company’s products were implicated in at least 19 serious injuries and two deaths during the same period. At inspections of the firm’s Missouri, New Jersey and Texas facilities in 2013, inspectors found multiple problems regarding the cleanliness of the facilities and quality controls. Yet the FDA has done little to correct these problems.

“Over the past two decades, the FDA has failed in its role as a public health agency by allowing compounding pharmacies to encroach further and further into the realm of drug manufacturing,” said Carome. “These firms have been allowed to grow in size to the point where they can drive mainstream manufacturers out of business, at least for certain products. Yet the products they sell are so far removed in quality from FDA-approved products that few consumers would knowingly choose to be treated with them, were the true differences rendered transparent.”

Any strategic plan by the FDA to confront drug shortages should include the following elements:

- The FDA must step up enforcement against companies representing themselves as compounding pharmacies;

- The FDA should not rely on unregistered facilities to supply the market with unapproved products in times of shortage;

- The FDA should work with manufacturers of FDA-approved products to increase production or bring facilities into compliance with good manufacturing practices, or expedite review and approval of new products. If no FDA-approved version of a product is available, the FDA should work with comparable foreign agencies to import products approved in other countries under standards similar to the FDA’s;

- The Centers for Medicare and Medicaid Services should not allow federal programs to reimburse for unapproved drugs;

- The FDA should not waive good manufacturing practices requirements through the exercise of enforcement discretion unless all other options have been exhausted and the product is necessary to prevent death or other serious injury;

- The FDA should ensure that purchasers are informed of regulatory actions taken during a shortage, especially any decisions to waive good manufacturing practices requirements; and

- Records of FDA inspections of drug manufacturing facilities should be made public as soon as they are completed.

To read Public Citizens comments, visit http://www.citizen.org/hrg2103.

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