15 April 2010
Contrary to the actions of the company advertising, promoting and selling the Simply Slim product, the Medicines Control Council (MCC) would like to put it on record that the product in question (Simply Slim) still remains suspended until data on safety, quality and efficacy of the product has been evaluated by the MCC.
It has come to the attention of the MCC that the company Simply Slim has re-launched or intends to re-launch the product in defiance of the MCC directive of 27 January this year. The directive was for the product not be marketed or sold until such time that it has gone through the regulatory processes of the MCC requiring amongst others supportive data on the safety, quality and efficacy of the product.
To date Simply Slim has not submitted such data to the MCC for purposes evaluation by the controlling body.
The MCC based its decision to suspend the sale of the product after it was discovered that the product contained sibutramine, a schedule five substance. Medicines containing schedule five substances may only be sold on a prescription from a doctor and under the personal supervision of the physician.
A number of complaints received from the public by the MCC regarding the product include serious or life threatening adverse events such as psychological effects, kidney complications and cardiovascular events.
The MCC therefore resolved that the risks associated with the use of
Simply Slim by the public are greater than the benefits and until such time as the MCC has evaluated the safety, quality and efficacy of the product the MCC prohibits the sale thereof.
For more information please contact:
Fidel Hadebe
Tel: 012 312 0663
Cell: 079 517 3333
Issued by: Department of Health
15 April 2010
1 comment:
SIMPLY SLIM's RESPONSE TO MEDICINES CONTROL COUNCIL MEDIA STATEMENT OF 15 APRIL
A Media Statement issued by the Medicines Control Council (MCC) this morning is contrary to agreements and undertakings made by the MCC, according to Simply Slim.
Following the undertaking by Simply Slim to recall their imported product from the market, Simply Slim, through their legal counsel advised the legal counsel of the MCC on 4 March 2010, that:
• the decisions taken by the MCC on 2 February were ultra vires and procedurally unfair
• these decisions were both appealable and reviewable
• they will be manufacturing the product locally in an MCC-approved facility subject to stringent quality and safety controls.
Simply Slim extended an invitation to the MCC to discuss the quality and safety measures but received no response.
As a result Simply Slim had no alternative but to file a formal notice of appeal, in terms of Section 24 of the Medicines and Related Substances Act (Act 101 of 1965), which had the effect of an automatic suspension of the decisions of the MCC, which meant that Simply Slim was entitled to continue to sell the imported product, pending the outcome of the appeal.
Since 5 February, the company has also sought the following information and documentation in terms of the Promotion of Access to Information Act of 2000 from the MCC:
• Minutes of the MCC Council meeting of 27 January
• Tape recordings of this meeting
• Documentary proof of all the tests that had been conducted on Simply Slim
• Documentary proof of- and investigation reports on- all health-related complaints made about Simply Slim
To date, none of this information or documentation has been provided.
Simply Slim has since given notice to the Director General of Health in terms of Section 3 of the Institution of Legal Proceedings Against Certain Organs of State Act (Act 40 of 2002), that they are also taking the impugned decisions on review to the North Gauteng Division of the High Court of South Africa, after they had initially agreed to hold over the notice pending a promised response which did not materialise.
Simply Slim obtained a Registry Number for the new product from the MCC on 29 March 2010 as per the document shown hereunder:
On 30 March 2010 the Director Legal Services of the Department of Health, informed Simply Slim that the “MCC discussed the matter in their meeting held on 19 March 2010; in which meeting the Council directed Legal Services to arrange a meeting with the applicants, Simply Slim (Pty) Ltd or their legal representative, as the case may be, with the aim of discussing a way forward in this regard.”
A meeting was held on Thursday 8 April between representatives of the company, members of the MCC and their legal representatives. It was confirmed at this meeting that the decisions of the MCC related to the imported product (as destroyed through the recall process). The MCC representatives and their legal counsel undertook to provide Simply Slim with a letter confirming this on or by 16 April, hence the company’s great surprise at the MCC’s Media Statement of today’s date. The MCC at this meeting also confirmed that their only interest was the interests of the public and Simply Slim assured them that the new product complied with their current good manufacturing process guidelines and that pre- and post- manufacturing quality controls are in place. In addition a customer safety mechanism has been implemented to ensure authenticity of the product. The net result of this is that any legitimate concerns which the MCC might have had have been negated. This further demonstrates Simply Slim’s commitment to the safety and well-being of their customers.
ENDS
Issued by:
Lance Rothschild
Tel: 082 443 1530
E-Mail: lance@opportunate.co.za
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