Drug & Device News

FDA Chief's Blog Offers Help Line to Frustrated Patients

In an entry to his blog called “Andy's Take,” Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, discussed the challenges faced by patients who have tried FDA-approved conventional medications without relief and therefore want to gain access to investigational or restricted therapies. Stated Eschenbach, “My take is that once approved treatment regimens have been exhausted, desperately ill patients should have appropriate access to any reasonable treatment that has the potential to be of benefit and yet doesn't present unjustifiable risks.” Doing this, however, has often proved difficult, if not impossible. To help consumers work through the process of gaining access to investigational and restricted medical therapies Eschenbach suggests they call the FDA's Office of Special Health Issues at 301-827-4460. There, FDA personnel are standing by to help patients navigate the system. Explained Eschenbach, “To permit such treatment use of an investigational drug, the company must first agree to make the drug available. Then, the FDA, in conjunction with the patient's treating physician, must determine, among other things that the potential benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or the condition to be treated; and that providing the investigational drug for the treatment use will not interfere with the initiation, conduct, or completion of clinical investigations that are required to support marketing approval of the investigational drug for the greatest number of patients who can benefit.”

FDA Seizes Contaminated Heparin Products from Ohio Company

The FDA on Nov. 6, 2008 seized several lots of heparin, the blood anticoagulant, from an Ohio drug manufacturer. The agency had earlier found that a component of the product, which was imported from China, contained over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Although the tainted heparin was discovered and segregated from untainted products months before the seizure, the FDA seized the lots because, it said, the affected drug manufacturer, Celsus Laboratories Inc. of Cincinnati, had failed to give adequate notifications to buyers of potential problems with products already sold.

Law Preventing Marketers From Using Prescribing Information Upheld

On Nov. 18, 2008, the U.S. Court of Appeals for the First Circuit, in IMS Health Inc. v. Ayotte, — F.3d —-, 2008 WL 4911262, C.A.1 (N.H.), Nov. 18, 2008 (NO. 07-1945), upheld a New Hampshire state law that prohibits marketers from using information about doctors' prescribing habits for commercial reasons. Pharmaceutical companies purchase this type of data from information brokers and drug stores so that their sales representatives can use it to tailor their pitches to doctors. The law in question is different from other states' laws in that it does not allow prescribers to opt in or out of a prescription information-sharing program.

The court ruled against the data miners because they did not have standing to sue, as the subject speech was that of pharmacies, pharmaceutical companies and doctors, rather than of the data mining companies. The court went on, however, to describe how it would have ruled on the merits, had it reached them. It rejected arguments that New Hampshire's Prescription Information Law unconstitutionally restricts commercial speech, finding that the law's ban on the use, transfer, sale or licensing of prescription information that is patient- or prescriber-identifiable was “reasonably calculated to advance [the State's] substantial interest in reducing overall health care costs within New Hampshire.” Quoting Justice Oliver Wendell Holmes in Frohwerk v. U.S., 249 U.S. 204 (1919), the court said: “The First Amendment, while prohibiting legislation against free speech as such cannot have been, and obviously was not, intended to give immunity for every possible use of language.”

FDA Agent Impersonators Are Extorting Money from Consumers

The FDA has issued a warning to consumers of a scheme being perpetrated by swindlers preying on the fears of U.S. drug consumers who purchase medications internationally. The ruse works like this: Someone calls a home and talks the occupant into “buying” drugs from them, telling the purchaser to wire money for the medications to the Dominican Republic. No drugs are ever sent to the buyers, but the scammers later call back, claiming to be FDA special agents. These “special agents” tell the purchasers that they are in violation of the law for attempting to buy drugs internationally and they must send a fine of several thousand dollars to an address in the Dominican Republic if they want to avoid jail time. Says Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, “The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business.”

Cleveland Clinic Promotes Transparency in Doctor/Pharmaceutical Company Ties

The well-respected Cleveland Clinic has posted an online directory of all its physicians, disclosing not only their educational and professional background data but also information on any relationships they might have with the drug and device industries. Included in the listing is information about each doctor's equity stakes in drug manufacturing companies, as well as their rights to receive royalties from those companies. If they have a fiduciary relationship with a drug company or perform consulting services for it and receive more than $5,000 per year, this information will also be posted. In a statement issued by the Cleveland Clinic, the Clinic's Chief of Staff, Joseph Hahn, M.D., said, “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations. As far as we are aware, Cleveland Clinic will be the first academic medical center in the U.S. to disclose to its patients and the public the industry ties of its physicians.”

FDA Chief's Blog Offers Help Line to Frustrated Patients

In an entry to his blog called “Andy's Take,” Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, discussed the challenges faced by patients who have tried FDA-approved conventional medications without relief and therefore want to gain access to investigational or restricted therapies. Stated Eschenbach, “My take is that once approved treatment regimens have been exhausted, desperately ill patients should have appropriate access to any reasonable treatment that has the potential to be of benefit and yet doesn't present unjustifiable risks.” Doing this, however, has often proved difficult, if not impossible. To help consumers work through the process of gaining access to investigational and restricted medical therapies Eschenbach suggests they call the FDA's Office of Special Health Issues at 301-827-4460. There, FDA personnel are standing by to help patients navigate the system. Explained Eschenbach, “To permit such treatment use of an investigational drug, the company must first agree to make the drug available. Then, the FDA, in conjunction with the patient's treating physician, must determine, among other things that the potential benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or the condition to be treated; and that providing the investigational drug for the treatment use will not interfere with the initiation, conduct, or completion of clinical investigations that are required to support marketing approval of the investigational drug for the greatest number of patients who can benefit.”

FDA Seizes Contaminated Heparin Products from Ohio Company

The FDA on Nov. 6, 2008 seized several lots of heparin, the blood anticoagulant, from an Ohio drug manufacturer. The agency had earlier found that a component of the product, which was imported from China, contained over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Although the tainted heparin was discovered and segregated from untainted products months before the seizure, the FDA seized the lots because, it said, the affected drug manufacturer, Celsus Laboratories Inc. of Cincinnati, had failed to give adequate notifications to buyers of potential problems with products already sold.

Law Preventing Marketers From Using Prescribing Information Upheld

On Nov. 18, 2008, the U.S. Court of Appeals for the First Circuit, in IMS Health Inc. v. Ayotte, — F.3d —-, 2008 WL 4911262, C.A.1 (N.H.), Nov. 18, 2008 (NO. 07-1945), upheld a New Hampshire state law that prohibits marketers from using information about doctors' prescribing habits for commercial reasons. Pharmaceutical companies purchase this type of data from information brokers and drug stores so that their sales representatives can use it to tailor their pitches to doctors. The law in question is different from other states' laws in that it does not allow prescribers to opt in or out of a prescription information-sharing program.

The court ruled against the data miners because they did not have standing to sue, as the subject speech was that of pharmacies, pharmaceutical companies and doctors, rather than of the data mining companies. The court went on, however, to describe how it would have ruled on the merits, had it reached them. It rejected arguments that New Hampshire's Prescription Information Law unconstitutionally restricts commercial speech, finding that the law's ban on the use, transfer, sale or licensing of prescription information that is patient- or prescriber-identifiable was “reasonably calculated to advance [the State's] substantial interest in reducing overall health care costs within New Hampshire.” Quoting Justice Oliver Wendell Holmes in Frohwerk v. U.S. , 249 U.S. 204 (1919), the court said: “The First Amendment, while prohibiting legislation against free speech as such cannot have been, and obviously was not, intended to give immunity for every possible use of language.”

FDA Agent Impersonators Are Extorting Money from Consumers

The FDA has issued a warning to consumers of a scheme being perpetrated by swindlers preying on the fears of U.S. drug consumers who purchase medications internationally. The ruse works like this: Someone calls a home and talks the occupant into “buying” drugs from them, telling the purchaser to wire money for the medications to the Dominican Republic. No drugs are ever sent to the buyers, but the scammers later call back, claiming to be FDA special agents. These “special agents” tell the purchasers that they are in violation of the law for attempting to buy drugs internationally and they must send a fine of several thousand dollars to an address in the Dominican Republic if they want to avoid jail time. Says Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, “The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business.”

Cleveland Clinic Promotes Transparency in Doctor/Pharmaceutical Company Ties

The well-respected Cleveland Clinic has posted an online directory of all its physicians, disclosing not only their educational and professional background data but also information on any relationships they might have with the drug and device industries. Included in the listing is information about each doctor's equity stakes in drug manufacturing companies, as well as their rights to receive royalties from those companies. If they have a fiduciary relationship with a drug company or perform consulting services for it and receive more than $5,000 per year, this information will also be posted. In a statement issued by the Cleveland Clinic, the Clinic's Chief of Staff, Joseph Hahn, M.D., said, “We want our patients to have abundant information about our physicians and let them decide what's relevant to their situations. As far as we are aware, Cleveland Clinic will be the first academic medical center in the U.S. to disclose to its patients and the public the industry ties of its physicians.”