Product News and Recalls

Professor: Limits on FDA caused outbreak

A Boston University law professor claims legal limitations on the U.S. Food and Drug Administration are indirectly responsible for a national meningitis outbreak that has sickened more than 400 people and killed 31.

A story in the Los Angeles Times deals with the allegations made by Kevin Outterson, who specializes in healthcare law and pharmaceutical markets.

In 2002, Outterson says, the Supreme Court overturned provisions of a 1997 law that would have given the FDA more authority to regulate compounding pharmacies such as the one responsible for the current outbreak.

Investigators have identified a specialty pharmacy called the New England Compounding Center as the source of tainted steroid medication that caused the outbreak. Meningitis is an inflammation of the tissue surrounding the spinal cord and the brain.

According to the story, the Supreme Court case concerned the FDA’s attempt to prevent compounding pharmacies from advertising the drugs they sell.

The rationale was that the pharmacies are supposed to fill prescriptions only for drugs that aren’t readily available, such as low-dose pills, or a liquid form of a medicine that is normally sold in a capsule. Under those circumstances, the FDA contended that advertising was unnecessary.

But seven pharmacies challenged the 1997 law in court, arguing that it amounted to an unconstitutional restriction of free speech. Justices sided with the pharmacies in a 5-4 vote. As a result, other provisions of the law wound up in regulatory limbo, including some that would have prevented the outbreak, Outterson said.

Among them were provisions that would have prevented the pharmacies from making significant quantities of drugs before having prescriptions for them in hand; from using manufacturing or testing equipment designed for large commercial operations; and from disregarding the laws and regulations of the states where they operate.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.

See the story here:

http://www.latimes.com/health/boostershots/la-heb-fungal-meningitis-outbreak-regulation-20121108,0,2241751.story