Drugs in each of the categories have helped and improved life. However, their affordability for the masses due to high prices is becoming increasingly limited.
FDA has issued guidelines that I believe have created more stress when it comes to manufacturing technology innovation. They have not created platform/s to simplify existing manufacturing operations and introduce better technologies. In addition, FDA has not tried to simplify filing process and reduce approval times.
Examples are FDA’s suggestion are adoption of QbD (3,4)and continuous manufacturing (5)for the manufacture of Active Pharmaceutical Ingredients (APIs) and their formulations. It is necessary to mention that the fundamentals of chemical engineering that have been outlined in McGraw Hill Chemical Engineering Series (6)and earlier versions going to early fifties have been practiced in the manufacture of chemicals, pharmaceuticals being a subset. They detail the fundamentals that are the building block of every chemical manufacturing process, have been practiced since inception, but are being labeled as the new “coming” (3,4) necessary for quality products.
Continuous improvement is an ongoing exercise at every organization. FDA has been preaching it but has it practiced on its own practices. Case in point is that FDA had not done much to simplify drug or approval of manufacturing processes. A recent proposal to bring the time to eight to ten months has been suggested. Even that has issues. My question is why not complete the whole task in three months. Benefits will be tremendous i.e. lower costs and selling prices and competition. Pharma needs these. Only best of the best will survive.
Manufacturing technology innovation comes from the companies that produce products. In the last 20 years very little of new manufacturing technologies and for that matter continuous improvements, my conjecture, has taken place on the pharma landscape that are able to lower brand and generic manufacturing costs and selling prices. I believe regulations, extended approval procedures and time are the cause. I also believe that caution within the companies, regulators will take too long to approve improvements and better technologies, are also a reason for lack of any innovation within the companies.
I believe there is more following of FDA guidances/suggestions rather than companies taking internal initiatives that will improve product quality, profitability and drug affordability. A latent reason for all this could be high profitability with existing less than efficient processes and methods.
Industry has to take the lead on manufacturing technologies. Current global pharma and that includes regulatory landscape will need significant change to get there (9).
Hatch-Waxman Act (10)and WTO (11)changed global pharma landscape.
When nearing patent expiration not much effort through efficient processes, which could slow down or prevent generic entry, has been made by the brand companies to retain manufacture of drugs in the developed countries. As a result most of the generic drugs are being manufactured and supplied by the India and China. Selling prices of the generics are lower compared to the brand drugs. Hatch-Waxman and WTO helped. However, the selling prices of the same generic drugs are significantly, by magnitude, lower in the developing countries compared to the developed country prices. This price differential is raising many questions about loss of intellectual property, an unfair question. Main reason for the high prices is exorbitant price hikes by the supply chain participants (12,13)especially in the United States to facilitate drug distribution.
Industry seems to have lost its mojo in developing breakthrough therapies for mass needs. It has produced marginally better drugs that it can sell at much higher prices to keep its revenues and profits growing. High prices have helped revenue and profit growth. With waning growth, industry has focused on cancer therapies, where it has made significant advances, and on orphan drugs. Demand especially for cancer drugs is significant. However, industry has to figure out how to make these drugs affordable. Big question is “Can the industry sustain its current business model?”
Companies selling brand drugs in the developing countries at significantly lower prices are causing consternation in the developed countries. There are too many examples to enumerate. That gives the perception in the developed countries is that the developing countries are stealing intellectual property. Reality is very different. Since the brand pharma cannot sell the drugs at the developed country prices, they sell the same drugs at significantly lower prices to recoup some of their fixed expenses. Since the major suffering population could be in the developing countries, it would be beneficial if the brand companies used ‘economies of scale’ to sell the drugs all over at lower prices and amortized their investment over a longer period. This could be considered an alternate business model.
Industry and the regulators have to figure out how to reduce drug development and approval time and costs. Question we need to ask and address is that are we over analyzing the drug development and their commercial processes and as a result delaying new drug introduction at affordable costs. Industry needs to consider 7.2 billion population as the market rather than 1.2 billion. It should be obvious that the revenue from 7.2 billion would be much bigger number. Are the companies missing on simple laws of economics?
Companies will have to comply with every FDA requirement and have to have fool proof compliance regimen. If they do not, FDA should stop manufacturing at the site. Inspection and approval time could be extended beyond three months. Reducing time to three months will be an internal challenge at FDA.
Companies have to do an internal introspection of their own practices so that they do not suffer the wrath of 483s. Every step of the manufacturing process they have to have an absolute command. One may think that this is difficult. It is difficult only if one has command of the processes. They have to think that if a manufacturer is expecting quality, they should deliver the same, no less.
, Accessed March 1, 2018