Despite what you might have read in a recent Congressional report, drug shortages are neither the exclusive fault of the FDA, nor does the FDA represent the entire solution.
Monday, at the big BIO bash, I spoke on a panel about the issue. My complete remarks can be found here. The gist of my comments is that, while the FDA has an important role to play – the role of economics (ASP, 340B rebates, Group Purchasing Organizations) are the primary reasons we find ourselves in the fix we’re in.
A few points:
* Market price stability is crucial. A US government analysis of average sales prices shows that oncology sterile injectables that experienced shortages since 2008 decreased in price from $56.17 per unit in Q1 2006 to $37.88 per unit in Q1 2011. Oncology sterile injectable drugs that have not experienced shortages have had relatively stable prices over this same period.
* Safety is non-negotiable. Alleviating a shortage by shorting GMPs is a bad and dangerous pathway. Expediency causes as many problems as it solves.
* That being said, regulatory discretion must be part of the solution. With 30% of production capacity off-line because of FDA issues, the agency must work with manufacturers to find creative, science-based solutions. My fellow panelist, Gerry Migliaccio (senior vice president of network performance at Pfizer) said his experience with other regulators around the world is that if you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.
* The FDA might allow some temporary fixes that fall in line with that thinking, explained the FDA’s Jouhayna Saliba (senior regulatory program manager at the FDA's Drug Shortage Program). If a company discovers impurities that could be filtered out, the agency might allow the product to be shipped along with filters and explanations of how they are to be used in order to avoid a shortage, she said.
* Who inspects the inspectors? Per that 30% of manufacturing capacity off-line due to FDA issues, I challenged Jouhayna to undertake an agency audit to see why there’s been such a jump in GMP issues. It’s hard to believe that year-over-year, production quality control has suffered such a significant lapse. Is there something wrong in the way FDA inspectors (many of them still wet behind the ears and eager to please) are doing their jobs? It’s a question worth asking – and answering.
For a brief 5-minute BIO-produced video on the topic, see here.
As Saliba said, "This is not a problem that is going to go away soon."
But the sooner the better.
Richard Feynman said, “The worthwhile problems are the ones you can really solve or help solve.”
Drug shortages are a worthwhile problem to solve – and we need to keep our collective eyes on the prize.
Monday, at the big BIO bash, I spoke on a panel about the issue. My complete remarks can be found here. The gist of my comments is that, while the FDA has an important role to play – the role of economics (ASP, 340B rebates, Group Purchasing Organizations) are the primary reasons we find ourselves in the fix we’re in.
A few points:
* Market price stability is crucial. A US government analysis of average sales prices shows that oncology sterile injectables that experienced shortages since 2008 decreased in price from $56.17 per unit in Q1 2006 to $37.88 per unit in Q1 2011. Oncology sterile injectable drugs that have not experienced shortages have had relatively stable prices over this same period.
* Safety is non-negotiable. Alleviating a shortage by shorting GMPs is a bad and dangerous pathway. Expediency causes as many problems as it solves.
* That being said, regulatory discretion must be part of the solution. With 30% of production capacity off-line because of FDA issues, the agency must work with manufacturers to find creative, science-based solutions. My fellow panelist, Gerry Migliaccio (senior vice president of network performance at Pfizer) said his experience with other regulators around the world is that if you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.
* The FDA might allow some temporary fixes that fall in line with that thinking, explained the FDA’s Jouhayna Saliba (senior regulatory program manager at the FDA's Drug Shortage Program). If a company discovers impurities that could be filtered out, the agency might allow the product to be shipped along with filters and explanations of how they are to be used in order to avoid a shortage, she said.
* Who inspects the inspectors? Per that 30% of manufacturing capacity off-line due to FDA issues, I challenged Jouhayna to undertake an agency audit to see why there’s been such a jump in GMP issues. It’s hard to believe that year-over-year, production quality control has suffered such a significant lapse. Is there something wrong in the way FDA inspectors (many of them still wet behind the ears and eager to please) are doing their jobs? It’s a question worth asking – and answering.
For a brief 5-minute BIO-produced video on the topic, see here.
As Saliba said, "This is not a problem that is going to go away soon."
But the sooner the better.
Richard Feynman said, “The worthwhile problems are the ones you can really solve or help solve.”
Drug shortages are a worthwhile problem to solve – and we need to keep our collective eyes on the prize.
