Big Hairy Audacious Goals set doers apart from talkers.
Last week, “under the patronage of the Lebanese Ministry of Public Health,” I was honored to participate in the two-day “Drug Quality Forum” held at the American University of Beirut.
The focus of the event was on the impact of drug quality and safety with focused presentations on (among other topics) API quality, GMP requirements (as well as the often forgotten but hugely important GSDPs – Good Storage and Distribution Practices), data requirements and regulatory pathways. In attendance were senior health ministry officials from Lebanon, Syria, Jordan, and Iraq as well as representatives from the WHO and France’s Agence nationale de sécurité du médicament et des produits de santé (ANSM) – née AFSSAPS.
Some brief verbatims:
David Holt (St. George’s University, London): “There is nothing more expensive than clinical failure.” He also cited the following from a recent paper in the British Journal of Pharmacology (2011;72:727-30)
“There are few prospective studies assessing potential additional risks associated with substitution and there are no established protocols by which switching is monitored or assessed.
This may make it difficult to know whether the money saved on the initial drug will still be saved as treatment outcomes on the substituted drug become apparent.”
Gilberto Lopes (The John’s Hopkins Singapore International Medical Center) pointed out that it’s not about the cost of pharmaceuticals but rather spending on pharmaceuticals – and that having more new therapies is a good thing.
Mark McGrath (Novartis) made the very important point that, “Quality cannot be implied.” This followed on my earlier comment that “Quality cannot be tested into a product. Quality is by design.”
At the end of the first day, Conference chairman, Dr. Joseph Simaan (Professor and Chairman, Department of Pharmacology and Toxicology, Faculty of Medicine, American University of Beirut), commented that public health officials are faced with “a moral dilemma” of wanting (and being under pressure) to approve locally manufactured generics – but cannot, in any way, allow sub-standard products onto the market.
As Khahil Gibran wrote, “Perplexity is the beginning of knowledge."
Day Two focused on topics ranging from bioavailability to bioequivalence and biowavers – highly technical presentations, but not without some humor. One example:
Q: Why were the two generic chemists so sad?
A: They were dissolutioned.
(Who said drug regulators don’t have fun?)
On that same topic, Soula Kyriacos (Pharmaline) gave a very informative talk on the correlation of product dissolution and bioavailability (in vitro vs. in vivo). And take my word for it – anything sounds riveting when presented by a smart woman speaking English with a Lebanese/French accent.
The last session of the meeting was devoted to developing a series of consensus recommendations for the attendees to take back to their respective nations within the GCC (Gulf Countries Cooperative). I was pleased to help moderate this effort along with Dr. Simaan, Dr. Ghassan Hamadeh (Associate Dean for CME, Faculty of Medicine, American University of Beirut) and Dr. Ziad Nassour (President of the Lebanese Order of Pharmacists).
Here are those recommendations:
1. Ministries of Health (MOH) to develop criteria for approval of bioequivalence centers (CROs) in compliance with International standards (GCP, GLP) in line with FDA, EMA, WHO or ANSM mechanisms for inspection and approval.
2. MOH to ensure that complete, detailed, and well-documented files are submitted for registration of all drugs according to ICH guidelines.
3. Any biosimilar application for an imported product must include a prior EMA or FDA approval
4. MOH must insist on emphasis of the quality of the active ingredient with full information on sourcing, materials and manufacturer.
5. Information leaflets of generic and innovator drugs should be up to date and made accessible and include all safety information.
6. No marketing approval for drugs without stability, and bioequivalence studies according to ICH guidelines.
7. No marketing approval for drugs not approved or marketed in their country of origin.
8. MOH to initiate product specific pharmacovigilance systems.
9. MOH to set up an efficient communication system to be used by Health Care Professionals and the Public to report safety issues with drug products
10. Drugs should not be sold in dispensaries. (Note: In Lebanon, “dispensaries” are supposed to provide generic medicines for those who cannot afford to buy them at no charge.)
11. Create a Department for Quality Control within the Ministry of health to review, authenticate submissions and inspect dossiers as well as track batches and perform random testing of marketed products.
12. Ensure all drugs are available through controlled supply chain.
13. Build capabilities in the ministry of health through enhanced training in
Big Hairy Audacious Goals? Absolutely.
That’s precisely what makes them so exciting.