Florida appellate court upholds Florida law against generic drug switching - even if the generic has been FDA approved

Today, a Florida state appellate court ruled that a Florida law banning the substitution of certain drugs must be followed, even if a generic version gets federal approval from the Food and Drug Administration.

A three-judge panel of the 1st District Court of Appeal unanimously said it would be unconstitutional for the Florida Legislature to give up its authority over generic swaps to the federal Food and Drug Administration.

The Florida law lists the drugs for which generics cannot be substituted. The appellate court ruled that the Legislature has to make any changes in that list.

The court sided with Abbott Laboratories, which appealed Administrative Law Judge Susan B. Harrell's decision to remove a thyroid drug, including its name-brand Synthroid, from the list.

"It upholds a fundamental right of patients to receive the medications that are prescribed and intended by their doctors," said Abbott spokesman Scott Stoffel in Chicago.

Abbott's drug is prescribed for patients whose thyroid glands don't make enough of a hormone that regulates energy and metabolism. Synthroid also is used to treat or prevent goiters - an enlargement of the thyroid gland - that can result from hormone imbalances, radiation treatment, cancer or surgery.

Harrell had ruled that a generic version made by Mylan Pharmaceuticals Inc. could be substituted because the FDA in 2007 had given it an A rating, which meant it was the therapeutic equivalent of Synthroid.

Harrell based her ruling on another provision of the law that removes a generic from the list if it gets an A rating in the FDA's "Orange Book."

District Judge William A. Van Nortwick wrote that Harrell should not have applied that provision to editions issued after the law was passed in 2001.

It's up to the Legislature to update the list each year based on revised versions of the Orange Book, though it isn't required to follow the FDA's guidance, Van Nortwick wrote.

Source: http://www.miamiherald.com/news/florida/AP/story/1108552.html

Debate about Generic Drug Substitution & US Marshals seize Generic Drugs from Caraco Parmaceutical Detroit-Based Plant Today

The headline about US Marshals seizing drugs and raw materials from a generic drug manufacturer grabbed my attention today and reminded me about what I heard earlier this week about 'generic drug substitution' or 'therapeutic switching.'


Generic Drug Substitution:

A debate seems to be brewing about pharmacists dispensing generic versus the brand name drug written on the prescription. A few days ago, it was reported that people suffering from epilepsy that are given generic, instead of the suggested brand named drug, are having increased seizures. This 'therapeutic switching' or generic substitution

Read the Detroit Free Press article. "To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne's seizures. In the next week, Cheyenne, age 11, had 21 seizures -- many more than usual."

A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.

Usually, a doctor can stop a switch by writing "DAW" on a prescription. But problems still can occur, and appeals are time-consuming. The Michigan Osteopathic Association (7,000 members) and the 3,000-member Michigan Association of Family Physicians have some worries. They're concerned that the preference by many health plans toward generics and nearly equivalent drugs called therapeutic substitutes leave too many patients and their doctors out of the decision-making about which drug they can prescribe or use.

Today, generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by U.S. authorities for violating manufacturing standards.

This is rather troubling since Caraco manufactures and markets 67 different products, according to the company’s Web site. The FDA said the seizure could affect 33 drugs in different dosages. Sun Pharmaceutical Industries Ltd., a Mumbai, India-based drugmaker, owns 76 percent of Caraco’s stock, according to Sun’s Web site.

Drugs and raw ingredients for pain, heart ailment and psychiatric medications were confiscated today at three Detroit, Michigan facilities to prevent Caraco from distributing its products until the manufacturing deficiencies are corrected, the U.S. Food and Drug Administration said in their statement.

The FDA said drug seizure could lead to shortages of one pill, choline magnesium trisalicylate, a generic pain-relief medication. If you are taking this, the FDA suggested consumers to contact their doctors about other alternative pain-relief medications.

Inspectors who visited the Caraco facilities in May 2009 found “serious violations” of manufacturing standards and “serious deficiencies” in quality control, Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said in a briefing with reporters.

In October 2008, the FDA issued a warning letter to Caraco after inspections in May and June found manufacturing deficiencies, including the cross contamination of two drugs.

In April 2009, Caraco announced a voluntary recall of some undisclosed products, according to an April 17 federal regulatory filing.

During a May 2009 inspection of Caraco plants, the FDA found “unresolved violations” of manufacturing standards.

“Given the firm’s history, we thought this was the next appropriate step to protect the public’s health,” Autor said.

Corrective actions had been taken and “continual improvements” are being made while Caraco works with the FDA to resolve the agency’s concerns, the company said in a statement.

The drug seizure “may have a material adverse effect” on near-term operations, though the company hasn’t determined the financial impact, Caraco said in its statement.