One View--Regulate Compound Pharmacies With Care

From The Free Press, Mankato, MN

October 30, 2012

Our view: Regulate compound pharmacies with care

— So far, 24 people who have died of fungal meningitis after they were injected with tainted steroids made at a compounding pharmacy in Massachusetts. Another 328 people in 18 states have fallen ill, including nine in Minnesota.

What those patients didn’t know is that the pharmacy that made the steroids and others like it have been largely exempted from Food and Drug Administration oversight.

More FDA oversight in the specialty businesses is needed, but it should be done in a way that does not bring onerous regulation to the many small compounding pharmacies that provide a valuable service for patients and doctors.

Most of the compounding pharmacies are small operations that custom-mix drugs, such as specific compounds to treat children or seniors who can’t easily swallow pills.

The small, specialized industry didn’t come under the same regulation as large drug makers who must ensure they’re operating sterile facilities in a safe manner.

But some compounding pharmacies have grown into mega-drug manufacturers that are pushing the legal limits.

An FDA official warned in 2003 that some large compounders were using “creative marketing” to sell drugs they claimed were superior, without any evidence of support. Still others were manufacturing drugs they claimed were unique, when they were in fact simply cheaper versions of existing drugs.

Regulation of compounding pharmacies has been left to the states, with some assuming that role well while others are unprepared to provide real oversight.       

Congress will need to find ways to rein in so-called compounding pharmacies that are operating in an unsafe manner. But they and the FDA must also be careful not to put needless and costly regulations on legitimate smaller operations.

Source found here

Compounding pharmacies have long evaded the tight oversight governing established drug makers Mass. congressman seeks tougher rules for compounders

Lawmakers’ calls for tougher regulation of compounding pharmacies are nothing new. Over decades, there have been a series of attempts at the federal level to rein in a business that has largely evaded the kind of stringent oversight established drug makers face. 

Read full Boston Globe article here

K-V Pharmaceutical Seeks Extension to File Chapter 11 Plan

By Joseph Checkler 
 

K-V Pharmaceutical Co. (KVPBQ) wants to extend the amount of time it can control its own bankruptcy case without the threat of rival proposals, as the company continues trying to sort out issues regarding its flagship premature birth drug, Makena.

In a Friday filing with the U.S. Bankruptcy Court in Manhattan, K-V said it wants until March 4, to file a plan of reorganization without the threat of competing proposals and until May 2, to solicit votes on that plan. Without court approval, the company's right to file the plan and seek the votes would expire on Dec. 3 and Jan. 31, respectively.

"The purpose of the Debtors' present request for an extension of the Exclusive Periods is, among other things, to ensure that the Debtors have an opportunity to seek to address the concerns of all stakeholders," K-V said in its filing.

K-V's bankruptcy, like its business before it filed for Chapter 11, centers on the success of Makena. K-V bought the rights to Makena from Hologic Inc. (HOLX) in a deal that closed last year. Hologic, which K-V still owes money tied to Makena, is trying to get the rights to the drug back. It claims that K-V has made missteps that have sapped value out of the drug.

When Makena hit the market, K-V sold it for $1,500 per shot, a price that set off protests from detractors who said the drug was too costly. The Food and Drug Administration then decided not to take action against "compounder" companies making cheaper drugs using the same active ingredient as Makena, which hurt the drug's sales. K-V eventually lowered the price.

Although the FDA clarified its statement about Makena in June, the company thought it didn't go far enough and sued. A judge threw out the initial lawsuit, though K-V could appeal.

Continue reading here

Report: Deaths, illness linked to compounding pharmacies not new

Lisa Schnirring  Staff Writer

Oct 29, 2012 (CIDRAP News) – Safety problems with products from compounding pharmacies even before the current multistate fungal meningitis outbreak led to at least 23 deaths and 86 serious illnesses or injuries in 34 states over the past decade, according to a report today from a Massachusetts congressman.

The 34-page report from Rep Edward Markey, D-Mass., is based on his staff's review of media reports, documents from the Food and Drug Administration (FDA), and records from pharmacy boards in all 50 states, Puerto Rico, and the District of Columbia.

In a press release today Markey said the report documents more than a decade of violations and problems at the nation's compounding pharmacies that are tied to lax oversight and gaps in legal authority.

Tainted methylprednisolone acetate injections from New England Compounding Center (NECC), based in Framingham, Mass., have now been linked to 354 infections, according to an update today from the Centers for Disease Control and Prevention (CDC). Most patients sickened in the outbreak have fungal meningitis, but the recalled injections were also used to treat joint problems, and 7 of the patients have peripheral joint infections.

The latest total reflects 16 more cases from the CDC's previous report on Oct 26.

No new deaths have been reported, holding the fatality number at 25. Rhode Island reported its first case, pushing the number of affected states to 19, according to the CDC.

In a statement today, Markey said violations have included selling copies of commercially available drugs, drugs made from ingredients that are not approved by the FDA, contaminated products, drugs without valid prescriptions, and large quantities of drug produced in a manner that resembles manufacturing.

Markey's report also found that the FDA has been trying to bolster its oversight of the compounding pharmacies since the early 1990s but said some compounding pharmacy trade groups have used the court system to challenge every effort. The report also suggests that state pharmacy boards don't typically or consistently oversee compound pharmacy drug safety and don't always provide enforcement action records that are easily searchable and publicly available.

"The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight," Markey said in the statement. "This tragedy demands the strongest response from Congress and federal and state authorities to ensure safeguards are in place to protect patients."

The report said the deaths and serious illnesses cited in the report are from FDA records and should be considered a conservative estimate, because in many cases documents noted adverse events but didn't specify the type or quantity. In other instances, it noted that the FDA warning letters were sent before the full health impact of the violations were realized.

Safety-related enforcement reports at the state level aren't typically found in the records that Markey's staff reviewed, because regulators appeared to focus mainly on traditional pharmacy licensing activities such as billing violations or having a licensed pharmacist on site.

Markey said in the statement that the compounding pharmacy sector has resisted federal oversight for years, with assurances that state regulators were adequately reviewing their activities. "This report demonstrates that this is simply not true," he said.

His review of media reports of safety problems and FDA enforcement actions since 2001 found 60 instances.

For example, in October 2002 fungus-tainted methylprednisolone injections made by a South Carolina compounder were linked to a meningitis death and at least three other infections. In August 2005, a Minnesota compounder recalled its ophthalmic solution after bacterial contamination was found and the CDC received two reports of lost vision linked to the company's solution.

In August 2011, Alabama's Department of Public Health reported that bacterial contamination in an intravenous nutritional supplement intended for hospitalized patients led to at least 19 illnesses and 9 deaths, according to the report. The investigation found that the compounding facility used tap water to clean a container that used for mixing the drug.

In another example, in July 2012 the FDA sent a warning letter to a Florida compounder after its injectable products were linked to eye infections. Inspectors found unsanitary conditions at the facility, including bacterial and fungal species at several locations.

Markey is a member of the House Energy and Commerce Committee, which has launched a probe of NECC. On Oct 16 Markey asked the Department of Justice to investigate whether NECC violated federal controlled-substance laws.

In related developments, Massachusetts health officials yesterday announced that the state's pharmacy board has shuttered a third compounding pharmacy after an unannounced inspection found environmental problems that pose questions about the company's compliance with nationally accepted pharmacy standards, according to a media briefing transcript.

Madeleine Biondolillo, MD, director of the Massachusetts Department of Health Bureau of Healthcare Safety and Quality, told reporters that no contamination was found and the investigation is still in its early stages, according to the briefing transcript. She added, however, "Due to a variety of notable findings regarding the conditions of the medication production areas, inspectors expressed concern for the sterility of products."

The company, Infusion Resource of Waltham, is managed by a former employee of another pharmacy that had business ties with NECC.

Elsewhere, the Florida Department of Health (FDH) on Oct 26 ordered that Rejuvi Pharmaceuticals based in Boca Raton suspend operations after a routine investigation in early October found several rule violations related to cleanliness, dispensing, compounding, and recordkeeping. The FDA said the company had been warned after an earlier inspection and failed to correct the problems.

See also:

Oct 29 Markey statement

Oct 29 Markey report

Oct 29 CDC fungal meningitis outbreak update

Oct 17 CIDRAP News story "Fungal meningitis toll rises as feds raid pharmacy"

Oct 23 CIDRAP News story "Fungal meningitis outbreak cases top 300"

Oct 28 Massachusetts Executive Office of Health and Human Services press briefing transcript

Oct 26 FDH press release

Source found here

Should More State Veterinary Boards Adopt Compounding Rules Similar to Those Adopted In Texas This Year?

 The focus lately has been on the state pharmacy board rules and regulations and the FDA rules and regulations.  However, some states have veterinary rules that address compounded medications.  For example, Texas this year adopted significantly new rules and regulations relating to the veterinary compounding word.  Click here to review blog post regarding Texas Veterinary Rules Relating to Compounding that became effective June 2012.  Should other states be doing something similar?