Many Indians are troubled by the warning letter issued to Wockhardt Ltd by the US Food and Drug Administration (FDA). Coming soon after the Ranbaxy Laboratories Ltd debacle, one starts to worry. Is this a US conspiracy to thwart the booming Indian pharmaceuticals companies? Are Western regulatory authorities overzealous in prosecuting companies of Indian origin?
Indian pharma companies exporting to the US or the European Union have to play by their rules of the game. The rules in the US are interpreted by the FDA. You have to comply with the system and its referees. Period.
Let us look at the track record of FDA with respect to regulatory action against pharma companies of non-Indian origin. If we look at the Inspections, Compliance, Enforcement, and Criminal Investigations section on the FDA website, it has more American companies indicted than non-American ones. In 2012, GlaxoSmithKline agreed to pay $3 billion for “promoting its best-selling anti-depressants for unapproved uses” and failing to report safety data about its top diabetes drug Rosiglitazone. Pfizer paid $2.3 billion in 2009 for off-label promotion and kickbacks. Abbott paid $1.5 billion in 2012, also for off-label promotion. All three were for violations of the US False Claims Act and had hired top legal talent to defend them. The only thing you could negotiate once you are fined is the settlement amount. Contrast this to India where two drugs suspended on 18 June had their suspension orders revoked within a month.
If you read the letter of 18 July issued by the FDA to Wockhardt, the picture is one of fudging, hiding, providing inaccurate information, impeding investigators from the inspection site, and a general lack of data integrity with inadequate processes to prevent data manipulation. At one place, “The uncontrolled documents indicate that up to 14% of vials had defects including, but not limited to, black particles, fibres, glass particles, sealing defects, and volume variations…however, a senior production officer at your firm stated that no investigations are performed when this occurs.”
And the ultimate Indian high caste indifference to bodily outputs: “…our investigators found that the washing and toilet facility located approximately twenty (20) feet (approximately 6 meters) from the entrance area to the Sterile Formulation (b)(4) manufacturing facility was found to have urinals that lacked drainage piping. The urine was found to fall directly onto the floor, where it was collected in an open drain. Stagnant urine was observed near the open drain. In addition, the investigators also observed what appeared to be mildew or other mold(s) in this toilet facility. The facilities used in the manufacture of drugs should be appropriately maintained and repaired, and remain in a clean condition.”
Witch hunting by FDA? Does not look like that to me. On the contrary, the letter to Wockhardt appears to be fair and suggests to Wockhardt ways to get out of the self-created mess.
Companies exporting to countries with well-regulated agencies should have known better. If you did not expect the heat in the kitchen and cannot stand it, do not get into it.
There will be short-term loss of face (and share price) but with disciplined compliance, pharma companies exporting to regulated markets can only flourish. Even if regulatory goalposts keep changing.
Will this have a trickle down effect on India’s own regulators? One hopes so. Specify the standards for quality and good manufacturing practice compliance clearly. There should be no need for any “setting” thereafter, nor “match fixing” of inspections allowed.
So is the FDA a white lily with perfect rules? No. It is like saying the umpire beats his dog, so overlook my ball-tampering.
S. Srinivasan is a public health activist and managing trustee, Low Cost Standard Therapeutics (LOCOST), a non-profit and small-scale pharma firm in Vadodara, Gujarat.