Articles from January 2010

FDA warns of bogus agents duping public

Consumers buying medicines over the Internet are already risking exposure to fake medicines, but are also being preyed upon by criminals posing as Food and Drug Administration officials.

The counterfeit officials are focusing on consumers who have brought medicines via the Internet or ‘telepharmacies’.

They call the victims and identify themselves as FDA special agents or other law enforcement officials, for example from the Federal Bureau of Investigation (FBI), Drug Enforcement Agency (DEA) or US Customs Service.

The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards, according to the agency. Read the full story on the Securing Pharma (Securing Pharma, 29st December 2009)

Bogus drug website operators face 12-year jail sentences

Specific criminal sentences for counterfeiting medicines are to be introduced in the UK. Convicted individuals would face a maximum penalty of 10-12 years’ imprisonment, the agency has announced. Individuals could be found guilty of either supplying or offering to supply counterfeit medicines.

Current penalties are seen as limited in scope and to be failing to provide any deterrent. The MHRA proposed earlier this year to develop such an offence.

It has now developed more detailed plans for how such a criminal sentence would work and launched a consultation on these proposals.

The definition of counterfeiting will include details about the packaging of products and the documentation supplied with them, the MHRA has said. However, other details of the language in which the offence would be couched have yet to be determined.

The agency is to look into whether a similar jail term could be established with EU-wide coverage, although the law will initially cover the UK alone. Read the full story on the Healthcare Republic (Healthcare Republic, 1st January 2010)

FDA conducts raids to check fake drugs

It seems that Muzaffarnagar in western UP is fast becoming a hub of fake and substandard drugs. The city topped the list followed by Varanasi in volume of illicit drugs seizure during a special drive undertaken by the Food and Drug Administration (FDA), UP in November.

Officials at FDA said that these special surprise inspections were carried out in 14 districts of the state to check the rampant trade of adulterated drugs across the state. During the raids eight special teams besides two reserve teams having officials from other districts, were deputed.

Spurious drugs worth Rs 1.04 crore were seized from Muzaffarnagar followed by drugs worth Rs 13.50 lakh from Varanasi during the operation. Lucknow came third where the raids yielded drugs worth Rs 11.50 lakh. Other major seizures included Agra (Rs 6 lakh) and Mau where drugs worth Rs 1.50 lakh were recovered. Read the full story on the Times of India (Times of India, 3st January 2010)

5,000 Web Sites Selling Prescription Drugs Outside of Pharmacy Laws and Practice Standards

On December 11, 2009, the National Association of Boards of Pharmacy(R) (NABP(R)) reached a bitter-sweet milestone in its ongoing review of Web sites selling prescription medications. NABP now lists more than 5,000 Internet drug outlets as Not Recommended. These sites — 96% of the total number of sites reviewed — have been found to be out of compliance with pharmacy laws and practice standards established in the United States to protect the public health.

Of the 5,231 Internet drug outlets NABP had assessed since the May 2008 launch of its Internet drug outlet review program, 5,008 (96%) of the sites were found to be out of compliance with basic criteria for legitimate pharmacy practice and were posted as Not Recommended on the NABP Web site. Of the 5,008 sites listed as Not Recommended:

  • More than 75% (4,029) dispense drugs without a valid prescription.
  • More than half (2,762) accept a brief online questionnaire in place of a prescription. To be valid, and to ensure patient safety, a prescription must be based on a legitimate patient-practitioner relationship that has included a face-to-face physical examination.
  • Nearly 25% (1,327) post a physical address located outside the US.
  • Nearly half (2,436) do not provide any physical address. According to the World Health Organization, more than 50% of medicines purchased over the Internet from sites that conceal their physical address are counterfeit.
  • Nearly half (2,216) offer foreign or unapproved drugs. Because these drugs are not subject to the quality and safety requirements of those approved for sale in the US — or even of those approved for sale in other developed countries — their safety and efficacy are unknown.
  • Nearly 20% (956) do not have secure sites that protect patients’ personal and financial information.

Read the full story on the PR Newswire (PR Newswire, 27th December 2009)